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Senior Medical Director, Pharmacovigilance

  • Job type: Permanent
  • Location: Bridgewater, New Jersey
  • Salary: Negotiable
  • Job reference: 192191/004_1533822006
  • Sector: Safety, EPM Scientific
  • Date posted: 09/08/2018

Senior Medical Director, Pharmacovigilance

  • Senior Medical Director, Pharmacovigilance

  • Northern, New Jersey

  • Excellent Salary + excellent bonus + excellent benefits

We have partnered with a clinical stage bio-pharmaceutical company focused on developing CAR-T therapies to target various oncology indications that is seeking a Senior Medical Director, Pharmacovigilance to join their rapidly expanding team. This company plans to increase their head count from 20 employees to 200 by the end of 2019! If you are looking for an opportunity to join an innovative cell therapy focused company, where you can have meaningful impact on the PV group and the company as a whole than don't hesitate to apply!

The Senior Medical Director, Pharmacovigilance will have the following responsibilities:

  • Responsible for the medical safety review of all available safety data generated from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds

  • Responsible for conducting signal detection activities, monitoring, evaluation, interpretation, management and communication of safety information

  • Leads the Safety Review Teams for assigned products and development compounds and is responsible for the management of ongoing and cross functional assessment of benefit risk profiles along with the related actions, including writing and updating of the benefit-risk documents for assigned products and development compounds

  • Provides medical expert safety review input into all critical documents for products in clinical development (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, INDs, CTAs)

  • Develop and implement the strategy for benefit-risk management for assigned products.

  • Responsible for the medical review of adverse event reports for seriousness, expectedness and causality

  • Interaction with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.

  • Maintains high level timelines and detailed timelines for all deliverables. Effective, consistent & regular tracking of project timelines to allow full transparency to the senior leadership

  • Ensure high quality planning and execution of external meetings and internal stakeholder meetings (e.g., IMs, Governance, DMCs, Regulatory Authority)

  • Authorship and review of key safety related documents (eg: protocol concept sheet, protocol, ICF, IB, SPA, BB, CSR, BLA, WMA, PSUR/DSUR, etc)

The ideal candidate will have the following skill set:

  • MD

  • Minimum of 8+ years experience in PV

  • Strong knowledge FDA and other international regulations

  • Excellent communication skills

  • Experience with Pharmacovigilance Risk Management / Medical Review

  • Gene/Cell Therapy

  • Fluent in Mandarin

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