Pharmacovigilance Case Processing Officer H/F Servier

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

Pharmacovigilance Case Processing Officer

Activities & Responsibilities

The Pharmacovigilance Case Processing Officer is responsible for :

• 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.

S/He participates to:

• 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.

S/He contributes 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.

Profile

• Healthcare professional or scientific background (e.g., pharmacy, medicine, life sciences).
• Minimum 4 years' experience in pharmacovigilance case management within an international environment.
• Excellent understanding of global PV regulatory requirements
• Proficient in pharmacovigilance databases and safety information systems.
• MS Office Suite and internal tools.
• Fluent in English (spoken and written).
• Detail-oriented, strong organizational skills, ability to work cross-functionally and manage timelines for assigned products/projects/deliverables

Nous sommes engagés pour l'égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l'expérience qu'à l'envie de s'engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.