Pv Agreement Manager

il y a 24 heures

BoulogneBillancourt, France IPSEN Temps plein

**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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