Job Title:\u00a0Medical Director Pharmacovigilance Location: Cambridge, MA\u00a0 Duration: 12 Months\u00a0 OBJECTIVES: \u2022 Support developmental programs, including both early and late stage development as required. \u2022 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. \u2022 Supporting Therapeutic Lead \u2022 Line management responsibilities for junior physicians and\/or scientists \u2022 Flexible to support compounds\/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs ACCOUNTABILITIES: \u2022 Expectation of GSL role for compound(s) both in development and marketed in close association with the TAL. \u2022 Company wide safety expert for his\/her compound responsibilities \u2022 Intimate knowledge of safety, including any emerging safety concerns and risk\/benefit profile for 'own' compounds with input for other compounds as needed. \u2022 Serving in a leadership capacity for complex and strategically important programs \u2022 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 \u2022 Training and mentoring of Pharmacovigilance Physicians and Specialists \u2022 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 \u2022 Maintain professional knowledge and accreditation by active participation in continuing medical education activities EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: \u2022 Qualified physician (Licence, e.g. GMC registered, preferred) \u2022 Knowledge of principles of epidemiology and statistics. \u2022 Critical thinking and analytical skills and ability to make high level decisions \u2022 Excellent oral and written communication skills including ability to present to large internal\/external groups \u2022 Good level of computer literacy with Microsoft applications \u2022 Minimum of 8 years experience in pharmacovigilance, clinical research or clinical development \u2022 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine
Website : http://www.eteaminc.com
eTeam was formed in 1999 with the goal of becoming the supplier of choice for clients, employees and contingent workers. Today, we’re one of the fastest-growing companies in New Jersey and ranked as one of the best companies to work for by Staffing Industry Analysts and New Jersey Business. We’re also an honored member of Deloitte’s Technology Fast 50. eTeam provides high-volume staffing, SOW and payrolling services to structured contingent workforce programs and projects across the U.S., Canada and India. We also offer contract-to-hire and direct placement. Our “No-Sell, Service-Only” approach has resulted in “Accelerated Hires,” lower costs, reduced risks and better service for Fortune 2000 Companies, Large System Integrators and Government Agencies.