Medical Director Pharmacovigilance

Cambridge, MA | Contract

Post Date: 07/11/2018 Job ID: 226806 Industry: ERT
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. 
• Company wide 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 (Licence, 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
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