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.
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
· 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: 25th December, 2015
Last Date: 25th December, 2015
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