Medical Director, Pharmacovigilance (t795)

  • Contract Duration: 12+ months,
  • Research & Development
  • Cambridge, MA

Website Lenox Executive Search

Description

Lenox Executive Search is seeking a Medical Director, Pharmacovigilance for a remote contract role with one of our global pharmaceutical clients. This is a contract role with the possibility of extension and/or conversion to FTE.

The Medical Director, Pharmacovigilance is responsible for the oversight of signal detection, aggregate reports and risk management activities for designated global/regional product(s), together with global safety lead responsibly as appropriate.

  • Supporting Therapeutic Lead
  • Line management responsibilities for junior physicians and/or scientists
  • Flexible to support compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs

Accountabilities of a Medical Director, Pharmacovigilance:

  • Expectation of GSL role for compound(s) both in development and marketed in close association with the Functional Lead.
  • Company wide safety expert for his/her compound responsibilities
  • Intimate knowledge of safety, including any emerging safety concerns and risk/benefit profile for ‘own’ compounds with input for other compounds as needed.
  • Serving in a leadership capacity for complex and strategically important programs
  • Responsible for development of documents and for negotiation with Regulatory authorities on safety matters involving these compounds. This includes but is not limited to: direct interaction with Regulatory authorities, authorship of safety summaries to support changes to the PI/SmPC, CCDS updates, significant contribution to MAAs and NDAs, authorship of Executive Summaries on special safety topics, authorship of Integrated Analyses of Safety (IAS) for CTDs, etc.
  • Training and mentoring of Pharmacovigilance Physicians and Specialists
  • Perform activities required to serve as Global PV physician including SMT chair.
  • Review and oversight of safety data, both non-clinical and clinical
  • Review and/or sign off of protocols, SAPs, clinical study reports, IBs, IMPD and other documents developed for submission to regulatory authorities
  • Interactions with external experts and regulatory agencies and partner/co-development companies
  • Review of safety data and participate in dose escalation decisions
  • Authorship and sign off of Safety Monitoring Plan/Risk Management Plan
  • Lead data analysis and writing of regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
  • Direct the set up of safety procedures and development of safety exchange agreements for co-development projects
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities

Education, and skills of a Medical Director, Pharmacovigilance:

  • Qualified physician (License, e.g. GMC registered, preferred)
  • Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development
  • 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
  • Knowledge of principles of epidemiology and statistics.
  • Critical thinking and analytical skills and ability to make high level decisions
  • Excellent oral and written communication skills including ability to present to large internal/external groups
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