Assoc Dir PhV Safety Physician
Date: Jul 23, 2022
Location: Bangalore, IN, 560052
Company: Teva Pharmaceuticals
Who are we?
Job Description
- Performing medical review of ICSRs for all products from clinical trials
- Accountable for medical evaluation/interpretation of aggregate safety data of assigned products including signal detection and evaluation, regulatory safety reports (PSUR, PADER, DSUR), and ad hoc safety review/assessments of assigned and other products
- Lead safety management for clinical development programs assigned including Company Sponsored, Investigator Sponsored, Compassionate Use, and Disease Monitoring Programs; liaise with other functional groups to contribute to overall study execution while ensuring safety strategy and operational excellence
- Lead and chair the Product Safety Group; Further be responsible to present decisions from Product safety group to relevant safety board or external safety board (ex: DSMB)
- Contribute to clinical documents with respect to safety data (e.g. protocol, IB, informed consent/assent form, clinical study report, integrated summaries of safety, Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, and other relevant safety related clinical documents
- Lead risk management activities for assigned products globally and contribute to the preparation of Risk Management Plans (RMPs), REMS, as well as management of these plans
Qualifications
MD/MBBS plus minimum 2 years of clinical practice
8 year minimum working in pharmacovigilance and drug safety area as a safety physician in pharmaceutical companies
Function
Sub Function
Reports To
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