Pharmacovigilance Case Processing Officer
- Gif-sur-Yvette, Essonne
- CDI
- Temps-plein
- Monitoring the activities outsourced to the service providers :
- Management of pre and post-marketing pharmacovigilance cases in line with the Case Management team and Service provider : book-in, data entry, documentation, coding, narratives, evaluation, quality control, medical review and submission of the cases to ensure compliance with regulatory requirements, with Safety Data Exchange Agreements and procedures in place
- 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 (root cause, CAPA) 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 so that he has adequate information to perform the outsourced activities.
- Requesting the update of ARGUS database configuration for studies, products, reporting rules, Reference Safety Information.
- Study team kick-off meeting and end of study meeting.
- Operational meetings with the vendors.
- Operational meetings with Business partners.
- Regular team meetings.
- LPVs and vendor training on case processing.
- Audits/inspections as Subject Matter Expert.
- 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.
- Health Care professional, Scientific.
- At least 4 years of experience in PV case management in an international environment.
- Knowledge of information systems dedicated to PV and in IT project management.
- Excellent knowledge of regulatory requirements at the worldwide level
- Fluent in English.
- Good IT experience: pack office and internal tools