Medical Director M-SERM

4 weeks ago

Hyderabad, India Thermo Fisher Scientific Full time

Essential Requirements:

Candidate should have the following minimum requirements:

At least 5 years of PV experience working as safety physician. Good experience in ICSR assessment, literature review, signal detection and aggregate report for both Pre-authorization and Post marketing products. Good experience on Argus /ArisG/LSS safety database. Served as therapeutic area lead or support for new business development meetings. Involved in any process improvement initiative. Participated in client audit or regulatory inspections. Involved in activities that require interaction with client concerns

Job description:

Identifies unusual or significant project related concerns encountered for self or a direct report and proposes strategies for preventing or correcting significant problems.  Participates in strategy calls, proposal development and bid reviews  Provides global leadership in medical safety and risk mitigation for specific projects/clients. This may include being the primary PPD medical contact for the client  Presents PPD standard medical/safety processes to prospective clients at business development meetings, and communication with medical communities to explore and expand PPD business. This includes participation in business development opportunities ( networking) at educational conferences and meetings  Contributes to departmental process improvement initiatives.  Maintains understanding of methods for recording time spent on project and administrative tasks, expense submissions and travel  Ensures tasks delegated to PVG are properly executed. Adheres to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues. Adheres to client SOPs/directives and project specific WPDs for assigned projects. Adheres to PPD’s corporate policies and SOPs/WPDs.  Provides medical consultation to team members and answer all project/study related medical questions. Communicates clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately.  Provides safety reporting training on assigned projects/studies, as requested.  Medically reviews adverse event and serious adverse event data from all sources (solicited, spontaneous, literature, etc) as contracted.  Provides medical review of adverse events of special interest, serious adverse events and clinical outcomes events reported in Clinical Trials.  Performs data review as specified in the client contract and data validation manual including review of coding listings and/or full safety data to assess for potential safety concerns.  Assists in writing (interpretation of safety data) and/or review of CSR, IND/NDA report, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc. to ensure that the medical content is accurate and complete. Manages signal detection activities, scientifically reviews periodic safety reports, contributes to label updates, supports dossier maintenance and risk management activities.

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