- 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
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Pharmacovigilance Case Processing Officer - Saclay, France - Servier
Description
The PV Case Processing Officer handles responsability for the management of pharmacovigilance cases subcontracted to a vendor from collection to submission.
Activities & Responsibilities
The Pharmacovigilance Case Processing Officer is responsible for :
S/He participates to:
S/He contributes to:
Profile
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