LCPPV France
FRANCE
il y a 2 jours
Overview
Local Contact Person Pharmacovigilance - France
Responsibilities
- The primary responsibility of this role is availability and regulatory compliance. Most of the work involves monitoring, reporting, and maintaining compliance, you will not have intensive daily tasks.
- The following are mandatory duties for both the Primary and Deputy LCPPV.
- Follow our company policies, standard operating procedures, and project-specific instructions.
- Complete all required training modules to maintain your qualifications and stay current with regulations.
- Register with your local health authority as required by local regulations and maintain this registration.
- Be available during local business hours, or 24/7 coverage when specifically required by project terms. Because availability is the core responsibility, a Deputy LCPPV is mandatory.
- You must provide your deputy's contact information and CV to HR via email.
- Respond to all requests and communications within 1 business day to ensure timely compliance.
- Fill out availability forms whenever you plan to be away so your deputy can cover responsibilities.
- Report adverse events within 1 business day or according to customer-specific timelines.
- Send weekly regulatory intelligence updates to keep us informed of local regulatory changes.
- Submit monthly LCPPV reports through our platform, documenting your activities and any relevant updates.
ADHOC tasks
- Submit regulatory documents and reports to local health authorities on behalf of our clients.
- Translate documents between the local language and English when required for regulatory submissions.
- Follow up on safety reports and adverse events with local authorities or healthcare providers.
- Communicate directly with regulatory authorities for inquiries, submissions, or compliance matters.
- Support the implementation of additional risk minimization measures as required by local regulations.
- Participate in client-requested meetings or audits when needed.
Requirements
- Fluency in English and French
- Pharmacist or MD
- Resident of France
This is a contract role. Only applicants from France will be considered.
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Entreprise
Barrington James Limited
Plateforme de publication
WHATJOBS
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