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Pharmacovigilance Medical Director - Oncology

  • Job type: Permanent
  • Location: Cambridge
  • Salary: $240000 - $270000 per annum, Benefits: excellent bonus + Stock Options
  • Job reference: ARTR031218643
  • Sector: Safety, EPM Scientific, Quality
  • Date posted: 12/03/2018
Pharmacovigilance Medical Director - Oncology
  • Pharmacovigilance Medical Director - Oncology
  • Cambridge, MA
  • Excellent Salary + excellent bonus + excellent benefits
Our client is a top 15 pharma company globally and they are seeking a PV Medical Director to join their Global Patient Safety Oncology team. This company has achieved high levels of success for its innovative therapies across the gastroenterology, neurology, inflammation, as well as oncology therapeutic areas.  If you are looking to get in with a stable, world-renowned biopharmaceutical company that prides itself on its patient-focused approach than this is the opportunity for you.

The Pharmacovigilance Medical Director – Oncology will have the following responsibilities:

The Pharmacovigilance Medical Director will 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.
  • Lead, train, and manage a team of PV Physicians and Specialists
  • Authorship and sign off of Safety Monitoring 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
  • Collaborate with other teams
The ideal candidate will have the following skill set:
  • MD
  • Minimum of 5+ years experience
  • Strong knowledge FDA and other international regulations 
  • Excellent communication skills
  • Experience with Pharmacovigilance Risk Management / Medical Review
  • Strong Oncology Experience is a must
 

 

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