Randstad Pharmacovigilance in Cambridge, Massachusetts

Pharmacovigilance

job details:

  • location:Cambridge, MA

  • salary:$190 - $221.84 per hour

  • date posted:Wednesday, April 18, 2018

  • job type:Contract

  • reference:24632

job description

Pharmacovigilance

Job Title: Medical Director Pharmacovigilance

Position Description

  • 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

Position Responsibilities

  • 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 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

Position Requirements

  • 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

  • 2-3 years clinical experience with patients following post-graduate training with significant knowledge of general medicine

Benefits

  • Medical, Dental, and Vision Insurance

  • 401K Plan with Company Match

  • Life and AD&D Insurance

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.