Medical Director Pharmacovigilance

Job Post Index 219312-Sy##
Location Cambridge, MA
Description: Job Description:
  • Support developmental programs, including both early and late stage development
  • Oversight of signal detection and risk management activities for designated global/regional product(s), together with global safety lead responsibly
  • Will assess documents prepared by PV Scientist, evaluate signals and make judgment
  • Will write/review section of report - final assessor/reviewer
  • 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
  • Expectation of GSL role for compound(s) both in development and marketed in close association with the TAL.
  • Company wide safety expert for his/her compound responsibilities
  • Serving in a leadership capacity for complex and strategically important programs
  • 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, 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
  • 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
Skills: Qualifications
  • Qualified physician (Licence, e.g. GMC registered, preferred)
  • Industry experience, several years experience after graduating from medical school (5+ years)
  • Safety/safety report experience
  • Needs to have experience in causality assessment, adverse reactions, and how to read results
  • Leadership and presentation skills: will be leading cross-functional meetings
  • Clinical trial experience preferred
  • 5 years experience needed
  • International board certified also accepted
  • Knowledge of safety, including any emerging safety concerns and risk/benefit profile for ‘own’ compounds with input for other compounds
  • Previous experience as Medical director or drug safety lead.
  • Knowledge of principles of epidemiology and statistics.
  • Critical thinking and analytical skills
  • Ability to make high level decisions
  • Excellent oral and written communication skills including ability to present to large internal/external groups
  • Good level of computer literacy with Microsoft applications
  • 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

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