Pharmacovigilance Case Processing Officer

The PV Case Processing Officer handles responsibility for the management of pharmacovigilance cases subcontracted to a vendor from collection to submission

Main responsibilities:

Monitoring Outsourced Activities & Case Management:

• Manage pre- and post-marketing pharmacovigilance cases processed by Service provider: book-in, data entry, coding, narratives, quality control, medical review, and submission of applicable cases.
• Ensure compliance with regulatory requirements, Safety Data Exchange Agreements (SDEA), and internal procedures.
• Perform weekly quality control of cases processed by vendors.
• Draft and validate deviation forms, root cause analysis, and CAPAs for cases submitted late to Regulatory authorities and other applicable recipients

Clinical Trial Support & Documentation:

• Review protocols and electronic case report forms (eCRFs); write Safety Management Plans (SMP) for clinical trials.
• Request updates for ARGUS database configurations (studies, products, reporting rules, etc.,).
• Provide necessary documentation and training to vendors to ensure high-quality outsourced activities.

Coordination & Oversight:

• Perform reconciliation with business partners, Local Pharmacovigilance teams (LPVs), and clinical databases.
• Participate in study kick-off/end meetings, operational meetings with vendors/business partners, and in audits/inspections as a Subject Matter Expert (SME).
• Contribute to process optimization, quality document writing, and the validation of vendor invoices.

Required skills & experience:

• Education: Healthcare professional or scientific background (e.g., Pharmacy, Medicine, or Life Sciences).
• Experience: Minimum of 4 years of experience in pharmacovigilance case management within an international environment

Hard skills:

• Regulatory Knowledge: Excellent understanding of global pharmacovigilance (PV) regulatory requirements.
• Technical: Proficient in pharmacovigilance databases (e.g., ARGUS) and other relevant safety information systems. MS office suite and other relevant tools
• Literature review: Understanding of the literature surveillance process.
• Quality Management: Skilled in quality control, CAPA drafting, and setting/reviewing Key Performance Indicators (KPIs).
• Tools: Mastery of MS Office Suite and internal safety tools.
• Languages: Fluent in English (both spoken and written).
• Vendor oversight: Setting up/Reviewing key performance indicators to follow outsourced activities

Leadership skills:

• Onboarding & Mentorship: Capacity to onboard new collaborators and provide necessary training and documentation to case processing vendors and LPVs.
• Audit and inspections: Serve as a Subject Matter Expert (SME) for assigned activities/processes.

Soft skills:

• Cross-functional Collaboration: Ability to work effectively with diverse teams outside of global safety unit, and external partners
• Strong Communication: Proficiency in participating in operational meetings and regular team interactions in an international environment.
• Organizational Skills: High level of organization to manage multiple tasks.
• Adaptability: Ability to contribute to process optimization