Specialist I, Patient Safety and Pharmacovigilance Operations

Responsibilities:

• Monitor and manage assigned PSPV shared mailboxes and intake channels, ensuring timely review and disposition of incoming reports and communications
• Perform initial review/triage of incoming information to identify potential adverse events (AEs), serious adverse events (SAEs), product quality complaints (PQCs), special situations, and other safety-relevant information
• Identify potential Individual Case Safety Reports (ICSRs) and ensure information is routed to the appropriate case-processing team or workflow within required timelines
• Categorize, assign, route, file, and archive mailbox communications according to established procedures
• Prioritize and escalate serious, urgent, medically significant, or time-sensitive safety information as required
• Perform routine reconciliation of PSPV mailboxes and intake channels/sources to confirm potentially reportable information has been appropriately identified, received and processed
• Support the development of training materials
• Track and archive safety-related training for internal teams and vendors
• Assist with audits, regulatory inspections, and inspection-readiness activities by providing intake records and supporting documentation, as needed
• Perform additional PSPV projects and activities as assigned

Preferred Skills, Qualifications and Technical Proficiencies:

• Ability to work in a dynamic environment to meet patient and corporate needs
• Excellent communication skills (verbal and written)
• Ability to collaborate with cross-functional teams and support multiple projects in a fast-paced environment
• Able to travel for up to 10% of time
• Flexibility to be in office more than 3 days week to meet any business needs (e.g., audits, regulatory inspections)

Preferred Education and Experience:

• Bachelor's degree in healthcare or life sciences degree such as RN or BSN, PharmD
• 1+ years in healthcare setting, pharma or biotech company
• Familiarity with global pharmacovigilance regulations and safety-reporting requirements is desirable