Job Title: Medical Director Pharmacovigilance
• 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
• 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 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
• Medical, Dental, and Vision Insurance
• 401K Plan with Company Match
• Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.