Pharmacovigilance Case Processing Officer F/M

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.

What We Are Looking For

Your Background:

• Education: Healthcare professional or scientific background (e.g., Pharmacy, Medicine, or Life Sciences).
• Experience: A minimum of 4 years of expertise in Pharmacovigilance (PV) case management, ideally within a fast-paced international environment.

Technical Expertise (Hard Skills):

• Regulatory Mastery: Deep understanding of global PV regulatory requirements and compliance standards.
• Systems & Tools: Proficiency in safety databases (e.g., ARGUS) and the MS Office Suite.
• Quality & Compliance: Proven track record in Quality Control, CAPA drafting, and managing Key Performance Indicators (KPIs).
• Vendor Oversight: Experience in supervising outsourced activities, including setting and reviewing performance metrics.
• Literature Surveillance: Solid understanding of the literature review and surveillance process.
• Languages: Full professional proficiency in English (both written and spoken).

Leadership & Impact:

• Mentorship & Onboarding: Ability to successfully integrate new collaborators and provide high-quality training and documentation to vendors and Local Pharmacovigilance Officers (LPVs).
• Subject Matter Expertise: Act as a key SME for your assigned processes during internal audits and external inspections.

Key Attributes (Soft Skills):

• Cross-functional Collaboration: A natural ability to build relationships and work effectively with diverse teams and external partners.
• Strong Communication: A confident communicator, comfortable participating in operational meetings and interacting within a global network.
• Organizational Excellence: Highly organized with the ability to manage multiple priorities simultaneously.
• Continuous Improvement: An adaptable mindset with a drive to contribute to process optimization and operational efficiency.