Pharmacovigilance Case Processing Officer

The Pharmacovigilance Case Processing Officer is responsible for managing pharmacovigilance cases subcontracted to a vendor from collection to submission, monitoring vendor activities, and ensuring compliance with regulatory requirements.

Requirements

• Monitoring the activities outsourced to the service providers
• Management of pre and post-marketing pharmacovigilance cases
• Management of cosmetovigilance cases
• Litterature surveillance process
• Reconciliation with business partners, LPVs and clinical databases
• Performing a weekly quality control of cases processed by the vendor
• Reviewing legal cases with B/R unit representative
• Drafting/Validating the deviation forms for cases submitted late to Regulatory authorities
• Reviewing the protocol, the eCRF and writing the Safety Management Plan for clinical trials
• Providing necessary documents and training to the vendor
• Requesting the update of ARGUS database configuration
• Participating in study team kick-off meeting and end of study meeting
• Participating in operational meetings with the vendors and Business partners
• Participating in regular team meetings
• Audits/inspections as Subject Matter Expert
• Contributing to setting-up key performance indicators to follow vendor’s activities
• Reviewing key performance indicators provided by the vendor
• Monitoring of case processing done by the LPV for pharmacovigilance
• Writing of quality documents related to case management
• Validating vendor's invoices
• Process optimization
• Onboarding of new collaborators