Drug Safety Associate

  • location: Cambridge, MA
  • type: Contract
  • salary: $200 - $221.84 per hour
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job description

Drug Safety Associate

job summary:




  • 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


 
location: Cambridge, Massachusetts
job type: Contract
salary: $200.00 - 221.84 per hour
work hours: 9 to 5
education: No Degree Required
 
responsibilities:
  • 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
 
qualifications:
  • 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: Pharmacovigilance
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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