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Opportunity for Pharmacovigilance Leader in Novartis

Opportunity for Pharmacovigilance Leader in Novartis

A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post: Pharmacovigilance Leader

Job Description:

Performs Pharmacovigilance activities for all assigned Novartis projects or products including identifying and analyzing safety signals based on a comprehensive evaluation of post marketing data and Serious Adverse Events (SAEs) from clinical trials.
1. Monitors the clinical safety of projects/products and responds appropriately
2. Performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of line listings of single cases, and preparation of investigator notifications.
3. Identifies safety signals based on the review of solicited or unsolicited single cases and confirm that they are not overlooked. Performs signal detection, monitoring and evaluation based on single cases, aggregate data and signal detection tools.
4. Provides input into responses to inquires from regulatory authorities or health care professionals on safety issues. Prepares safety data for health authority review boards. Provides input to responses for legal queries and CPO requests involving safety issues.
5. Provides Pharmacovigilance input to initial development of basic prescribing information and is responsible for Pharmacovigilance input into updates of this information.
6. Prepares medical input to aggregate clinical safety regulatory reports
7. Provides input to safety profiling and risk management plan
8. Provides guidance as appropriate to Clinical Safety Operations for the coding and causality/ expectedness assessment of adverse event reports.
9. Provides expert evaluation on the clinical context of adverse event reports, assessment on the medical conditions, and the implications on Novartis drugs.
10. Collaborates productively with colleagues from Clinical Research, Drug Regulatory Affairs, Medical Affairs, Medical Information, Statistics, Safety Data Management, Epidemiology and other related departments.
11. Participates in review of clinical study protocols/reports/other regulatory documents as needed.
12. Provides relevant input for IPT, ICT, and CTT meetings as needed.
13. Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.
Timeliness and quality of safety analyses, interpretations, and presentations
Compliance with internal and external regulations and procedures.

Candidate profile:

Medical Degree required. Specialty Board certification desirable. Useful additional degrees: Post graduate degree in Pharmaceutical Medicine; Master of Public Health in Epidemiology (or equivalent) Fluent in spoken and written English. Understanding in another major language (e.g. French, German, Spanish) preferred. 3 years clinical experience postdoctoral
· At least 3 years in drug development in a major pharmaceutical company including 2 years in drug safety at an operational or medical position
· Proven ability to analyze, interpret, discuss, and represent safety information both in writing and orally.
· Experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information.
· Experience with (safety or others) issue management
· Experience in drug development, clinical trial methodology, regulatory requirements, scientific methodo logy, statistics and writing of publications

Additional Information: 

Experience: 2-3 years

Industry Type: Pharma/ Healthcare/ Clinical research

Functional Area: R&D

Job ID: 178579BR

Location: Hyderabad
Last Date: 25^th December, 2015

MORE DETAILS Click on this link:

https://sjobs.brassring.com/tgwebhost/jobdetails.aspx?partnerid=13617&siteid=5260&jobid=2396579

Material Control

Material Control

https://drive.google.com/file/d/0B0jieIu-53bMeF8wTGFicnR1MTg/view?usp=sharing

Application are invited for Senior Research Fellow in Gokaraju Rangaraju College of Pharmacy

Gokaraju Rangaraju College of Pharmacy (GRCP) creates an environment that opens up new worlds of opportunity. The institute is a DSIR recognized Scientific and Industrial Research Organization (SIRO), accredited by NBA, affiliated to Osmania University and approved by AICTE. Having four research departments such as pharmaceutics, pharmaceutical chemistry, pharmaceutical analysis and quality assurance and pharmacology, many research staff and research scholars are contributing immensely to the scientific community. GRCP has received research funding from DST, ICMR, AICTE and private Industries such as Dr. Reddy’s laboratories, Laila Nutraceuticals, etc. GRCP has grown as a premier institution in the field of Pharmacy Education and Research in India and abroad. Alumni are well placed in India as well as abroad in various pharmaceutical companies, government organizations like drug control, research laboratories, etc., and in several well-known academic institutions.

Applications are invited from the eligible candidates to work as Senior Research Fellow (SRF) in Indian Council of Medical Research (ICMR) sponsored project no. DHR/HRD Fellow/Start up project/1/2013-14 under Dr. Raghavendra N.M. at Department of Pharmaceutical Chemistry, Gokaraju Rangaraju College of Pharmacy, Osmania University, Hyderabad.

Post: Senior Research Fellow (SRF)

No.of post: 01

Job Description

Candidates shall pursue drug design of novel Hsp90-BRAF inhibitors by bioinformatic tools. The designed compounds to be synthesized chemically and characterized by analytical parameters. Lead compounds would be screened for in vitro cell proliferation assays and proteomics analysis of Hsp90-client protein interactomes.

Candidate Profile

Candidate experience in molecular modeling, chemical synthesis, pharmacological screening including biochemical testing are encouraged to apply

Education: M.Pharm/ MS Pharm (Pharmaceutical Chemistry /Pharmacology/

Pharmacognosy/ Pharmaceutical Analysis).

Candidates with GPAT/CSIR-NET or equivalent examination qualification will be preferred.

Additional Information:

Experience: 0-5 years

Qualification: M.Pharmacy/ MS (Pharmacy)

Location: Gokaraju Rangaraju College of Pharmacy, Bachupally, Hyderabad, Telangana

Industry Type: Pharma/ Healthcare/ Clinical research

Duration: 3 years

Salary: Rs 18000 + 5400 = 23,400 per month

Functional Area: SRF

Interested candidate should send complete bio data to the principal investigator, Dr. Raghavendra N.M (Email ID:nmraghav7@gmail.com; srf.grcp@gmail.com) through email before15^th December 2015.

Shortlisted candidates will be informed through Email and will be called for interview at Department of Pharmaceutical Chemistry, Gokaraju Rangaraju College of Pharmacy, Bachupally, Hyderabad.
The selected candidate will be allowed to register for Ph. D program of Osmania University as per Institute's procedure, subject to availability of seats and fulfillment of other essential criteria as per rule.

Vacancies for M.Pharm as Research Associate/Research Scientist (4 Opening) in Kusum Healthcare

Vacancies for M. Pharm as Research Associate/Research Scientist (4 Opening) in Kusum Healthcare

Kusum Healthcare Pvt. Ltd. was founded in 1997, as a 100 % export-oriented unit, with its headquarters in New Delhi.The company's first formulation plant was started in Bhiwadi, Rajasthan in 2007. Another formulation plant is expected to come up shortly in Indore, Madhya Pradesh. Kusum Healthcare Pvt. Ltd. is part of Kusum group of companies which is fully integrated, young pharmaceutical group on fast track having two manufacturing units; one of them is Kusum Healthcare at Bhiwadi Rajasthan India and the second is Kusum Pharm at Sumy Ukraine. Both these manufacturing units are WHO GMPcertified and PIC/s compliant.

Post: Research Associate/Research Scientist

No.of post: 04

Job Description

Should have abilities to develop independently- stable, bioequivalent and robust formulations and its process as per European guidelines and USFDA guidelines.
- Should have experience in technology transfer of Solid Orals (Tablets, Capsules and Sachets), semi solids and Liquids.

- Experience of fluid bed processor (bottom+top spray), Extruder/Sphereonizer and Freeze Dryer is highly desirable

- Knowledge of GMP/Compliance.

- Knowledge of Quality by Design is desirable.

Candidate Profile

Experience : 1-3 Years (RA), 3-5 Years (RS)

Educational Qualification: M.Pharma

Additional Information:

Experience: 1-5 years

Qualification: M.Pharm
Location: Bhiwadi, Rajasthan

Industry Type: Pharma/ Healthcare/ Clinical research

Functional Area: R&D

End Date: 15^th December 2015

Mail in your CV at rajat.hr@kusumhealthcare.com,mansi.hr@kusumhealthcare.com

Opening for Pharmacists (132 Openings) in National Health Mission

Opening Opening for Pharmacists (132 Openings) in National Health Mission

For the effective implementation of National Health Mission in the State a separate Mission Directorate (NHM) has been created within the Directorate of Health headed by Mission Director. It has a Programme Management Unit (PMU) headed by a Deputy Director cum State Programme Officer and a Financial Management Unit (FMU) headed by Jt. Controller Finance. The Mission Directorate functions in close co-ordination with Directorate of Health and reports to the Principal Secretary (Health). The plans and budget of the vertical programmes have been integrated in the State NHM.

Post: Pharmacist

No.of post: 132
Bilaspur- 8(UR=5, SC=1, OBC=1, Gen IRDP=1)
Chamba- 11 (UR=4, SC=2, OBC=2, OBC IRDP=1, Gen IRDP=1, ST= 1)
Hamirpur- 8 (UR= 6, SC=1, SC IRDP=1)
Kangra- 31 (UR=12, SC=6, OBC = 5, SC IRDP=l, OBC IRDP= 1, Gen IRDP=4, ST IRDP = 1, Gen WFF=1)
Kinnaur- 3(UR=1, SC=1, OBC=1)
Kullu- 10 (UR=4, SC=2, OBC=1, OBC IRDP= 1, Gen IRDP=1, ST = 1)
Lahaul & Spiti- 1(SC=1)
Mandi- 20 (UR=9, SC=2, OBC=4, SC IRDP=1, Gen IRDP=2, SC WFF=1, ST=1)
Shimla- 14 (UR=6, SC=2, OBC=2, SC IRDP=l; OBC IRDP= 1, Gen IRDP=1, ST=1)
Sirmour- 9(UR=4, SC=2, OBC=2, Gen IRDP=1)
Solan- 7 (UR=1, SC=2,OBC=2, Gen IRDP-2)
Una- 10 (UR=5, SC=1, SC IRDP = 2, OBC IRDP =1, Gen WFF= 1)

Consolidated pay: Rs 8,910/- PM

AGE: i) Between 18 and 45 years.
ii) Below 65 years in the case of the retired person.

Essential Qualifications:
(i) 10+2 in Science or its equivalent from a recognized University / Board.
(ii) Bachelors degree / Diploma in Pharmacy or its equivalent from a recognized university or an institution duly registered by the Central / State Government.
(iii) Must be registered with Pharmacy council of the concerned State / Central Government.

Applications are invited from the desirous and eligible candidates to be engaged on contract basis for the following posts to be filled in different Districts (Blocks) of the State under National Health Mission, Himachal Pradesh initially until 31-3-2016, which is a renewable based on the individual performance and requirement of the Department. The selection will be made on the basis of direct interview at respective District Headquarter. The candidates who fulfill the requisite qualifications, experience and age criteria may apply to the concerned Chief Medical Officer, Himachal Pradesh on or before 30.11.2015 upto 4.00 PMon the prescribed form, alongwith Demand Draft of Rs.200/- in case of General (UR) candidate and Rs.100/- in case of SC/ST/OBC candidate, which can be downloaded from Website of the National Health Mission  www.nrhmhp.govt.in

Detail of post(s) and eligibility conditions are given as under against each post(s).

Application are invited for Pharmacist in PGIMER

Application are invited for Pharmacist in PGIMER

Applications are invited on plain paper for 2 Posts of Pharmacist in Drug De-Addiction and Treatment Centre. Department of Psychiatry, PGIMER. Chandigarh, These posts are purely temporary for One year.

Post: Pharmacist

No.of post: 02

Salary: Rs. 16380/- per month

Age: Upto 30 yrs

Qualification
Essential:
i) Senior Secondary with Science or its equivalent from a recognized University/Board.
ii) Diploma in Pharmacy from a recognized Institution/Board.
iii) Should be a registered Pharmacist under the Pharmacy Act 1948 Desirable
i) Degree in Pharmacy from a recognized Instilution/University
ii) Experience in dispensing and/or storage and dispensing of drugs in a reputed hospital or Institution or in a drug store of a pharmaceutical concern.

The applicants are required to submit their Bio-data (with self-attested photo coptes of all the supporting documents & one photograph) by 26.11.2015 till 5:00 PM in the office of Drug De-addiction & Treatment Centre, PGIMER. Chandigarh and to appear for personal intervsew along with original certificates on 03.12.2015 at 2:30 PM in Drug De-Addiction & Treatment Centre. PGIMER, Chandigarh

If large numbers of applications are received a wntten test will be conducted.

No separate interview letters will be sent.

No TA/DA will be paid.

http://pgimer.edu.in/PGIMER_PORTAL/PGIMERPORTAL/Vacancies/JSP/ViewAll.jsp?record=1493

Opportunity for B.Pharm, M.Pharm to join in CSIR | Stipend Rs. 28000 - 40000 per month

The Human Resource Development (HRD) Group of COUNCIL OF SCIENTIFIC AND INDUSTRIAL RESEARCH (CSIR), New Delhi, provides opportunities to bright young men and women in the form of direct Senior Research Fellowships (SRFs) and Research Associateships (RAs) for training in methods of research under the expert guidance of faculty members/scientists working in universities, laboratories and institutes of Government Departments and recognised laboratories of industry in various fields of science and technology.
Preference will be given to the research topics relevant to R&D programmes of CSIR Laboratories, in the new and emerging fields of science and in the areas of importance for development of scientific and technological capability of the country. The Fellowships/ Associateships are tenable in all the universities and deemed universities/IITs/postgraduate colleges/government research establishments including those of CSIR, R&D establishments of recognised public sector, industrial firms and other recognised institutions. Only bonafide Indian citizens are eligible for the award. The award is for fixed tenure and does not imply any assurance or guarantee for subsequent employment by CSIR to the beneficiary. CSIR reserves the right to determine the place in India best suited to provide necessary facilities in the areas of science in which the awardee is to specialize. Selected Fellows and Associates will have to devote their full time to the approved research programmes. Fellows and Associates are not permitted to take up any other remunerative jobs/assignments during their tenure.

Post: Senior Research Fellow, Research Associate

SENIOR RESEARCH FELLOWSHIPS
ESSENTIAL QUALIFICATIONS:
MSc/BE/B. Tech or equivalent degree with at least 55% marks and one publication in Science Citation Indexed (SCI) Journal and should have completed at least two years of post MSc/BE/B. Tech research experience as on the last date of application, as evidenced from fellowship/ associateship or from date of registration for Ph.D.
OR
MTech/ME or equivalent degree in engineering/technology with at least 60% marks.
OR
BE/B. Tech or equivalent degree with at least 60% marks and two years research experience as on
the last date of application.
OR
MBBS/BDS or equivalent with at least 60% marks and one year internship.
OR
BPharm/BVSc/BSc(Ag) or equivalent degree with at least 55% marks and one publication in SCI Journal and should have completed at least three years research experience as on the last date of application, evidenced from fellowship/associateship or from date of registration for Ph.D.
OR
MPharm/MVSc/MSc(Ag) or equivalent degree with at least 55% marks and one publication in SCI Journal and should have at least one year research experience as on the last date of application, evidenced from fellowship / associateship or from date of registration for Ph.D.
Documents in support of research, teaching (not below the undergraduate level) experience and Ph.D. registration should be attached.
Those who have been awarded PhD/MD/MS/MDS degree or have submitted their thesis for the award of PhD/MD/MS/MDS degrees are not eligible for the position of SRF. Those who are eligible for RA will not be considered for SRF.

EMPLOYED CANDIDATES: These fellowships are held on a full time basis. Therefore simultaneous employment elsewhere is not permitted. However, those desirous of pursuing higher studies, but employed presently, whether temporary or permanent may apply with an undertaking that if selected, they will resign from the job before taking up the fellowship. The application will be rejected if the undertaking is not enclosed.

STIPEND AND TENURE: Rs. 28000/- per month during entire tenure of fellowship or date of PhD viva-voce whichever is earlier. In addition, each SRF will receive a contingent grant of a maximum Rs. 20,000/-p.a. The grant will be provided to the University/Institution with which the SRF will be affiliated. SRFs will be given Rs. 3000/- (lump sum) extra on submission of Ph.D thesis in e-form. For details regarding format, etc. of e-thesis please see CSIR’s Unit for R&D of Information Products (URDIP)
SRF will be tenable initially for a period of two years. The term is extendable by one year on the basis of assessment of the progress already made as judged by three member assessment committee. Those who have held or are holding equivalent fellowships awarded under various schemes of all India grant giving agencies such as DST, DBT, ICMR, UGC, ICAR etc. may apply subject to the condition that the total tenure inclusive of CSIR fellowship shall not exceed three years. Those who have already availed, or would have availed by 31^st March 2016, equivalent fellowship etc. for 3 years need not apply. The combined tenure of JRF, if any, and SRF will not exceed five years. SRF will be terminated from the date of PhD viva voce or completion of tenure whichever is earlier. Those who are already holding equivalent fellowship should specify the reason for applying. The application is likely to be rejected if the reason is not specified.

Pharmacopoeial Tests for Different dosage forms

Tablet

·         Uniformity of weight

Weigh 20 tablets selected at random and calculate the average weight. Not more than two of the individual weights deviate from the average weight by more than the percentage shown in Table 2 and none deviates by more than twice that percentage.

Average weight of tablet	Percentage deviation
80 mg or less	10
More than 80 mg but less then 250 mg	7.5
250 mg or more	5

·         Uniformity of content

The tablets comply with the test if not more than one of the individual values thus obtained is outside the limits 85 to 115% of the average value and none is outside the limits 75 to 125% of the average value. If two or three of the individual values are outside the limits 85 to 115% of the average value and none is outside the limits 75 to 125%, repeat the determination using another 20 tablets. The tablets comply with the test if in the total sample of 30 tablets not more than three of the individual values are outside the limits 85 to 115% and none is outside the limits 75 to 125% of the average value.

·         Disintegration

Type of capsule		Disintegration time
Uncoated Tablets		15 minutes
Coated Tablets	film-coated	30 minutes
	other coated tablets	60 minutes
Enteric-coated Tablets	0.1M hydrochloric acid	Should not disintegrate in 120 minutes
	mixed phosphate buffer pH 6.8,	60 minutes.
Dispersible and Soluble Tablets		within 3 minutes
Effervescent Tablets		5 minutes

Capsule

A.  Content of active ingredients

Weight of active ingredients in each capsule	Subract from the lower limit for samples of			Add to the upper limit for samples of
	15	10	5	15	10	5
0.12 g or less	0.2	0.7	1.5	0.3	0.8	1.8
More than 0.12g And less than 0.3g	0.2	0.5	1.2	0.3	0.6	1.5
0.3g or more	0.1	0.2	0.8	0.2	0.4	1.0

B.  Uniformity of weight

Average weight of capsule contain	Percentage deviation
Less than 300 mg	10
300mg or more	7.5

C.  Uniformity of content:

The capsules comply with the test if not more than one of the individual values thus obtained is outside the limits 85 to 115% of the average value and none is outside the limits 75 to 125%. If two or three individual values are outside the limits 85 to 115% of the average value repeat the determination using another 20 capsules. The capsules comply with the test if in the total sample of 30 capsules not more than three individual values are outside the limits 85 to 115% and none is outside the limits 75 to 125% of the average value.

D.  Disintegration:

Type of capsule		Disintegration time
Hard Capsules		30 minutes
Enteric Capsules	0.1M hydrochloric acid	Should not disintegrate in 2 hours
	mixed phosphate buffer pH 6.8	60 minutes
Soft Capsules		60 minutes