Assoc Dir PhV Safety Physician

Who are we?

Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

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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