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location: Cambridge, Massachusetts
job type: Contract
salary: $188.56 - 221.84 per hour
work hours: 9 to 5
•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.
•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 program
•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 (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
skills: SOP, Pharmacovigilance, RMP (Risk Management Plan)
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.