Randstad US Medical Director Pharmacovigilance in Cambridge, Massachusetts
Medical Director Pharmacovigilance
salary:$180.41 - $212.24 per hour
date posted:Sunday, October 10, 2021
industry:Professional, Scientific, and Technical Services
Medical Director Pharmacovigilance
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location: Cambridge, Massachusetts
job type: Contract
salary: $180.41 - 212.24 per hour
work hours: 9 to 5
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
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 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)
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
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
skills: NDA, Maa, Pharmacovigilance, Regulatory Affairs Operations, Submissions
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.
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