Principal Pharmacovigilance Specialist

Essential Functions

• Provide oversight and direction as a PV subject matter expert, enhancing client service internally and externally.
• Oversee the development of detailed project/program specific, Working Practices, Work Instructions, and other documents as applicable (e.g., Safety Data Exchange or PV Agreements).
• Serve as a resource for Case Processing team for complex cases and escalated inquiries.
• Perform case follow up activities such as identification of information to be collected during follow-up.
• Creating and reviewing case narratives.
• Providing client notifications as required for case management.
• Supporting and contributing to the development of training materials and training delivery.
• Highlight areas of concern/discrepancies to the Principal PV Specialist, Case Processing and/or Manager, Case Processing when related to ICSRs.
• Acquire and maintain an up-to-date knowledge of global safety regulations for medicines.
• Peer reviews of cases for quality, consistency, and accuracy as needed.
• Perform Health Care Professional (HCP) review (as required).
• Mentors and trains less experienced staff.
• Other duties as assigned.
  

Necessary Skills And Abilities

• Strong verbal, written and interpersonal communication skills with clients, external and internal staff.
• Excellent project management skills.
• High level of accuracy and attention to detail.
• Advanced problem-solving skills and ability to resolve problems in a timely manner.
• Able to work independently and collaboratively in a multidisciplinary team.
• Excellent organization and prioritization skills with attention to detail.
• Advanced Knowledge of Pharmacovigilance.
• Advanced knowledge of PV Systems, such as Oracle Argus Safety, ARISg, or other safety databases.
• Self-motivated to maintain high efficiency and productivity levels and manage multiple projects and clients.
  

Educational Requirements

• Required: a Bachelor's degree in life sciences.
• Preferred: an advanced degree, RN, RPh, PharmD or equivalent.
  

Experience Requirements

• 10 years of related work experience.