Pv Agreement Manager
Il y a 2 mois
**Title**:
PV Agreement Manager
**Company**:
Ipsen Pharma (SAS)
Main role & responsibility
- Lead the implementation of Pharmacovigilance Agreements (PVAs) for all applicable Business
Partnerships, in full compliance with all relevant pharmacovigilance legislation
- Develop and implement a cross-functional business process for ensuring that all external partner
contracts involving pharmacovigilance commitments include the relevant terms of a Pharmacovigilance
Agreement (PVA)
- Ensure that all changes in legislation which could impact the effectiveness of PVAs are proactively
incorporated into Ipsen processes and the PVA template and negotiated for existing partner agreements
according to a risk-assessed prioritization via routine and ad hoc reviews and updates
- Develop and maintain a database and central filing system for all Business Partnerships and ensure that
there are up-to-date Pharmacovigilance Agreements (PVAs) in place for all applicable partnerships, in
compliance with relevant pharmacovigilance legislation
- Ensure that PVAs are initiated and delivered for all applicable new Business Partnerships
- Develop, maintain and implement a schedule for review of the Pharmacovigilance Agreements, aligned
with review of business contracts
- Define relevant Key Performance Indicators (KPIs) and quality standards and ensure that these are
measured and monitored, with implementation of corrective and preventive actions (CAPAs) if required
Knowledge, abilities & experience
Education / Certifications:
- Bioscience or science graduate, or a degree in business administration, or experienced healthcare professional
**Experience**:
- Minimum:
- Experience of working in pharmacovigilance or with pharmacovigilance contracts and service providers
- At least 5 years of experience in Pharmaceutical Industry/Pharmacovigilance
- Experience of negotiating effectively to deliver shared goals
- Good working knowledge of pre
- and post-marketing PV legislation
- Ideal:
- Experience of cross-functional team work
- Prior experience with regulatory authority inspections and internal audits, either in industry, a CRO, or a health
authority
- Experience in translating legislation to internal processes
Languages:
- Fluent in written and spoken English
Key Technical Competencies Required:
- Ability to understand the bigger picture whilst focusing on delivering the detail
- Strong team player with excellent networking and influencing skills
- Ability to prioritise own workload, work under pressure and achieve strict timeline targets
- Good verbal and written communication skills
-
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