PV Partnering Senior Manager - 8 months FTC / CDD 8 mois Groupe Talents Handicap

Are you ready to lead and innovate in a dynamic, patient-focused biopharmaceutical company?

Ipsen is a growing global specialty-driven biopharmaceutical company focused on innovation and specialty care. We aim to make a sustainable difference by significantly improving patients' health and quality of life, providing effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences, and Rare Diseases.

Why Ipsen?

Patient-Focused: The patient is at the heart of everything we do, and improving their outcomes is the deliverable of every strategy.

Employee Care: We care for our employees, who are the ambassadors making a real difference.

Bold Leadership: We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions.

Growth Opportunities: We offer a wealth of fulfilling challenges and growth opportunities in a fast-moving, game-changing organization.

About the Role:

The PV Partnering Senior Manager is the Deputy of the PV Agreement Director for decisions on operational aspects, processes, tool, audit inspection preparation conduct & follow-up.

Key Responsibilities:

• Act as Lead for the Global Agreement List (GAL) tool for Ipsen, driving proactively the maintenance, upgrade and continuous improvement of the tool.
• Pilot the monitoring of PV Agreement activities with commercial partners, in compliance with applicable regulations and Ipsen processes

For the Partner portfolio & Region, the PV Partnering Manager is responsible for :

• Lead the PV Partnering strategy, building collaboration internally with all relevant stakeholders & externally with the commercial partner
• Drive the oversight of commercial partners, as part of PV partnering governance structure

On the tool aspects for audit/inspection readiness and on the metrics aspects for decision making and escalation:

• Act as the key contact for the Global Patient Safety Agreement List (GAL) & be the GAL Master
• In strong collaboration with GPS PV Data & Systems team and GPS Process owners
• Continuously perform consistency checks & ensure that all changes related any PVA updates are correctly reflected by the PVA team in the GAL tool.

On the training aspects for audit and inspection continuous readiness purposes:

• Be accountable for PVA tool & process education/training for Ipsen internal stakeholders as well as external stakeholders.

Lead the PV Partnering strategy, building collaboration:

• Internally with all relevant stakeholders
• Externally with the commercial partner while ensuring appropriate Pharmacovigilance Agreements (PVAs) are in place with commercial partners, in full compliance with all relevant pharmacovigilance legislation and applicable processes.

Drive the oversight of commercial partners, as part of PV partnering governance meeting and structure.

Fully support any compliance activities, audits & inspections, as trusted and senior subject matter expert.

Qualifications:

• Bachelor's degree in life sciences, pharmacy, or a related field, or in business administration
• Extensive experience in Pharmaceutical Industry/Pharmacovigilance
• Experience of working in pharmacovigilance or with pharmacovigilance agreements and partnering
• Strong experience of negotiating effectively to deliver shared goals
• Strong experience of cross-functional teamwork
• Strong working knowledge of pre- and post-marketing PV legislation
• Strong experience with regulatory authority inspections and internal audits, either in industry, consulting, or health authority
• Fluent in written and spoken English

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