Title: Medical Director Pharmacovigilance
Location: Cambridge, MA (02139)
Duration: 12 months+
- 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
- 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:
- Qualified physician (License, e.g. GMC registered, preferred)
- 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’ experience in pharmacovigilance, clinical research or clinical development
- 2-3 year’s clinical experience with patients following post-graduate training with significant knowledge of general medicine.