The Principal Pharmacovigilance (PV) Specialist, Case Processing is primarily responsible for directional leadership of PV clients that are contracted for an extensive suite of PV services while collaborating with Client Services on standard service offerings. The Principal PV Specialist serves as a subject matter expert of PV to assist in creating related project documents and guidance as needed. The Principal PV Specialist, Case Processing acts with limited oversight and ability to research, implement and manage PV services as contracted or requested; is responsible for maintaining a working knowledge of Global PV requirements for marketed products; and ensures compliance with all applicable regulations and internal SOPs. The Principal PV Specialist also assists the team with peer review and data entry as needed.
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: Four years of related work experience.
