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Pharmacovigilance Operations Manager

Cambridge, Massachusetts

Post Date: 10/16/2017 Job ID: 1708 Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety

Our client is looking for an experienced Manager of PV Operations (Mgr PVOps). This new team member will play a key role in optimizing drug safety operations across various PV areas: clinical development, non-interventional studies and post-approval drug surveillance. DS PV works with CROs and global business partners which makes for diverse and complex PV environment.

The Mgr PV Ops ensures that drug safety operations in clinical development programs, and post marketing are aligned with DS PV policies and procedures, agreements and conventions. The Mgr. PVOps ensures that the PV procedures meet best industry standards of efficiency and compliance. The Mgr. PVOps oversees exchange of safety data between functional groups within the organization as well as between client and its Partners. The Mgr. PVOps is responsible for providing training to all representatives on their safety reporting responsibilities.

The Mgr. PVOps reports to the head of Drug Safety Operations and Systems.

Job  Responsibilities:
  • Take part in the daily management of the DS&PV function
  • Monitor compliance with regulations, PV agreements and internal SOPs
  • Work closely with PV Quality and Compliance to maintain a quality PV system
  • Ensure seamless and compliant Safety Data Exchange with all PV Partners and third parties
  • Ensure adequate AE collection in all clinical development and post approval medical research
  • Oversee or execute quality Adverse Event processes in house
  • Oversee Safety Operations both inhouse and outsourced
  • Represent DS& PV in selected clinical development or medical research project teams
  • Develop and organize AE reporting training for all representatives.


Qualifications/ Requirements:
  • BS in a Life Science degree and/or clinical degree (Pharm. D., RN, RPh.) required
  • Minimum 5 years of hands on experience in Pharmacovigilance operations
  • Strong quality focus, with a good understanding of quality systems
  • Be familiar with AE database systems (preferably Argus)
  • Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines;
  • Experience in SAE case management and development of case queries;
  • Experience with overseeing a call center
  • Excellent communicator, both oral and written. Thrive in teams.
  • Good medical writing skills
  • Be proactive and use a risk based approach in complex processes

Anna Korelis

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