Director, Pharmacovigilance (14-24)

Sarepta Therapeutics

Pharmacovigilance

August 7, 2014

The Pharmacovigilance Director will oversee clinical safety across various compounds in clinical development. This person needs to be highly motivated and is expected to provide innovative, critical, and strategic input and leadership

 

Primary responsibilities include:

  • Provide safety and pharmacovigilance expertise in-house and by consultation with outside vendors for all development programs.
  • Be accountable for identification, assessment and communication of potential safety signals; generate and analyze trend analysis reports.
  • Collaborate with Regulatory Affairs to ensure appropriate reporting of PV and drug safety information to regulatory agencies and prescriber community.
  • Lead development of SOPs for PV and drug safety monitoring.
  • Provide oversight and key input for review of new or on-going safety documents that ensure compliance with domestic and international regulatory requirement, such as protocols, safety summaries and regulatory reports.
  • Oversee preparation and quality control activities for key safety documents
  • Give key input in review and finalization of clinical protocols and other study-related documents
  • Collaborate with a team of professionals who provide medical monitoring support for ongoing clinical trails. Opportunity exists for direct medical monitoring of early clinical trials.
  • Develop relationship with and capture drug safety info from key groups, including partner companies, physicians, nurses and patient advocacy groups.
  • Provide input to potential in-licensing opportunities and pharmacovigilance agreements with commercial partners.

 

Education and Skills Requirements:

  • Medical Degree (MD) or international equivalent
  • At least 7 years experience in drug safety/pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency
  • Excellent verbal, written and presentation skills
  • Ability to build relationships and influence across disciplines and all levels

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