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Medical Director, Drug Safety

  • Job type: Permanent
  • Location: Boulder, Colorado
  • Salary: Negotiable
  • Job reference: 180404/004_1538765560
  • Sector: Safety, EPM Scientific
  • Date posted: 05/10/2018

Medical Director, Drug Safety

  • Medical Director, Drug Safety

  • Colorado

  • Excellent Salary + excellent bonus + excellent benefits

We have partnered with a small oncology focused biotech company headquartered in Colorado that is seeking a Medical Director, Drug Safety to join their rapidly expanding team! This company just received its first approval from the FDA, and with a strong pipeline of other indications this company is about to explode with growth. If you are looking for an opportunity where you can grow with a rapidly expanding organization whee you can have an impact from your first day than please don't hesitate to apply.

The Medical Director, Drug Safety will have the following responsibilities:

The Medical Director, Drug Safety 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 3+ years experience

  • Strong knowledge FDA and other international regulations

  • Excellent communication skills

  • Experience with Pharmacovigilance Risk Management / Medical Review

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