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Medical Director Pharmacovigilance

Katalyst Healthcares & Life Sciences
Cambridge, MA Full Time
POSTED ON 4/12/2025
AVAILABLE BEFORE 5/11/2025

Job Description

Job Description :

  • Support developmental programs, including both early and late stage development as required.
  • Responsible for the oversight of signal detection 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 :

  • Expectation of GSL role for compound(s) both in development and marketed in close association with the TAL.
  • Companywide 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, 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.

    • Education, Experience, Knowledge And Skills :

  • 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.
  • Good level of computer literacy with Microsoft applications.
  • Minimum of 8 years of 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.

    • Qualifications

  • Knowledge of principles of epidemiology and statistics.

    • Additional Information

  • Good working knowledge of project management activities.
  • Interpersonal and professional skills to interact at all levels including senior executives, contractors and colleagues.
  • Good written and verbal communication skills and ability to present and critically discuss data in both internal and external discussions.
  • Highly organized, with exceptional good analytical and reasoning capability, ability to multi-task and prioritize.
  • Thorough knowledge on analytical & numerical skills.

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