safety physician lead - v
- Randstad
- 7 - 10 Years
- Mumbai
- 3 years ago
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Job Description
job description
safety physician lead - v in mumbai
a) Performing medical review of ICSRs for all products from clinical trials
b) 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 assignedand other products
c) 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
d) 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 documents
f) 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
g) 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)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.
skills
pharmacovigilance, safety physician
qualification
M.E/M.Tech, MBBS, MDS, Medical-MS/MD
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Role/Responsibilies: safety physician lead - v
Contact Details:
Company: RandstadLocation(s): Mumbai
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Randstad
Randstad India is a division of Dutch-based Randstad Holding NV, a Dutch multinational human resource consulting firm headquartered in Diemen, the Netherlands.
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