Associate Director,Lead Physician , Safety Surveillance , Pharmaceutical , MBBS + MD

  • 10-19 yrs
  • Not Disclosed

Job Description

Safety Surveillance Lead Physician (Associate Director) with Teva Pharmaceuticalsa) Performing medical review of ICSRs for all products from clinical trialsb) 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 productsc) 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 excellenced) 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)e) 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 documentsf) 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 plansg) Lead ADR determination for label in the submission document and participate in label review and revision; key member for safety related label negotiation with regulatory agencies as part of initial submission of the first label h) Product responsible to oversee and review reports on safety issues,signals and their implications for the Company Core Safety Information (CCSI) and Core Risk Minimization Activities. Represent PV position to different committee.i) Guide PV scientists across product life cycle in safety regarding safety surveillance activities such as; medical review, signal detection and risk evaluation activities; provide support, training and continued improvement as appropriatej) Make informed decisions and formulate actions based on safety data including communication to appropriate interfaces (e.g., Product Teams, Management, Affiliates and Health Authorities)k) Effective stakeholder management: Collaborate with different functions both in Teva (Medical Affairs, Clinical Development, QA etc) and outside Teva (KOLs, Universities etc)l) The safety surveillance physician lead to support global launch activities for assigned products Support Legal Department in safety related legal litigation action. m) Perform due diligence on product safety evaluation of a new asset. The ideal candidate should have:, MD plus minimum 2 years of clinical practice , 5 year minimum working in pharmacovigilance and drug safety area as a safety physician in pharmaceutical companies, Good knowledge in FDA and EU regulations, Experience with NDA,BLA submissions in the US and MAA in Europe or of biosimilars, Experience in managing safety issues in pre,and post,marketing environment, Proven abilities on handing safety surveillance tasks and chairing safety committee meetings, Ability to work cross,functionally with an international team across multiple time,zones, Excellent communication skills in speaking and writing English, Full time position in our Bangalore officesLooking for MBBS + MD Candidates