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Director/Sr. Director, PV Medical Safety

New York, NY

Posted: 01/22/2021 Employment Type: Direct Hire Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety Job Number: 2695

Job Description


The Director/Senior Director, Global Pharmacovigilance (PV) Medical Safety is a key role, providing Medical Safety input to the global PV organization and the company.  The incumbent participates in all aspects of medical safety related activities, including but not limited to signal detection/management, protocol review, risk management, ICF review, aggregate report review and ICSR Medical Review, as well as other medical safety activities. The Director/Senior Director will provide PV medical safety input to other functions and departments.  The incumbent is action oriented and ready to take on the challenges at a small, growing company. This position requires frequent and competent hands-on involvement in all Medical Safety activities within the PV function, and reports to the Senior Vice President, PV.

Key Responsibilities:
  • Conduct medical safety surveillance of products in development and marketed products, including signal management and risk management.  Evaluate AESI and identify new potential signals.  Prepare and present Safety information in cross-functional safety committees.  Propose needed actions with emerging signals.
  • Contribute and review aggregate reports including to DSUR, PADER/PBRER, as well as RMP.
  • Review clinical trial protocols from PV/Safety perspective.  Review Safety portions of ICFs.  Participate in study teams as PV representative.
  • Medically review ICSRs for clinical SAEs and serious postmarketing ICSRs.
  • Key role in safety sections of IND, NDA/BLA and responses to queries.
  • Have input to and surveillance of establishment and maintenance of appropriate quality management system to ensure support.

Qualifications:
  • Medical degree (MD or equivalent).
  • Experience in oncology recommended.
  • Minimum of 5-10 years pharmaceutical PV experience, knowledge of domestic and international safety regulations/requirements, NDA filing experience.
  • Thorough understanding of regulatory environment for PV with working knowledge of FDA and ICH guidelines.
  • Hands on experience in pre-marketing and postmarketing PV settings required.
  • Experienced in working in a PV department in small company.
  • Experience with safety databases including Argus and ArisG.

Meet Your Recruiter

Tracey Goldthwaite
Senior Vice President

Tracey spearheads the firm’s Commercial practice and focuses on identifying and placing individuals in leadership roles within Global Marketing, Medical Affairs, New Product Planning, and Patient Advocacy and Engagement, to name a few. With 25 years of experience, she also plays a key role in the Clinical Staffing practice, recruiting top talent of all levels for positions in our core areas including Clinical Operations and Development, Regulatory Affairs, Pharmacovigilance and Program Management.

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