Location: Cambridge, MA (Onsite)

Objectives:

• 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 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 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 setup 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

Medical Director PV:

• Industry experience, several years’ experience after graduating from medical school (5+ years)


• safety/safety report experience


• will assess documents prepared by PV Scientist, evaluate signals and make judgment - needs to have experience in causality assessment, adverse reactions, how to read results


• will write/review section of report - final assessor/reviewer - must have good written communication skills


• leadership & presentation skills: will be leading cross-functional meetings


• clinical trial experience preferred, but not necessary


• 5 years’ experience needed


• possibility of extension/conversion, prefer to look at candidates who have potential to convert


• ARGUS/safety database experience not needed


• GMC preferred but not required


• international board certified okay

Requirement:

• 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