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Ipsen Global

Global biopharma focused on specialty care

Head of Safety Partnering

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeNo salary listed

About the Job

Requirements

  • A bachelor's degree in life sciences, pharmacy, or a related field, or in business administration.
  • Strong expertise in change management to support strategic vision.
  • Extensive team management experience.
  • Strong leadership and experience negotiating effectively to deliver shared goals.
  • Significant experience in pharmacovigilance within the pharmaceutical industry.
  • Proven expertise in pharmacovigilance agreements.
  • Extensive experience in global partnering environments.
  • Strong stakeholder engagement and negotiation experience.
  • Solid understanding of global pharmacovigilance regulations and inspection readiness.
  • Robust working knowledge of pre- and post-marketing pharmacovigilance legislation.
  • Robust experience with regulatory authority inspections and internal audits, either in industry, consulting, or a health authority.
  • Fluency in English.

Responsibilities

  • Define, lead, and deploy Ipsen’s global pharmacovigilance partnering strategy for commercial partners across the portfolio.
  • Build internal collaboration with relevant stakeholders and external collaboration with commercial partners, ensuring pharmacovigilance agreements are in place and comply with relevant legislation and processes.
  • Drive oversight of commercial partners within the pharmacovigilance partnering governance structure.
  • Define and lead the safety partnering strategy for global and local commercial partners in alignment with Ipsen’s product strategy.
  • Lead internal alignment and communication of the pharmacovigilance partnering strategy and ensure key stakeholders understand it.
  • Oversee and be accountable for pharmacovigilance agreements and partnering with Ipsen commercial partners at global level.
  • Conduct due diligence for product acquisitions and divestments.
  • Lead or support setup and maintenance of pharmacovigilance agreements and safety data exchange agreements aligned with Ipsen product and safety partnering strategies.
  • Drive implementation of signed pharmacovigilance agreements with relevant stakeholders and promote shared understanding of roles and responsibilities; ensure ongoing education of internal and external stakeholders for compliant execution.
  • Lead internal pharmacovigilance discussions and negotiations with partners, ensuring clear and efficient stakeholder communication.
  • Lead termination negotiations with partners and internal stakeholders, terminating pharmacovigilance activities in accordance with Ipsen processes, strategy, and regulatory requirements.
  • Oversee and drive pharmacovigilance regulatory intelligence related to partnerships and develop a global safety partnership regulatory intelligence strategy.
  • Ensure internal processes align with global pharmacovigilance regulations and internal standards.
  • Proactively incorporate legislative changes affecting pharmacovigilance agreement effectiveness into templates and implement them for impacted agreements.
  • Lead and develop the Safety Partnering team.
  • Ensure appropriate team resourcing, capability building, and performance management.
  • Foster a collaborative, high-performance team culture.

About the Company

Ipsen Global

Global biopharma focused on specialty care

Ipsen is a global biopharmaceutical company that concentrates on specialty care, developing and marketing medicines for oncology, neuroscience, and rare diseases. Its products work by treating specific high-need conditions, ranging from historical diarrhea treatment Smecta to modern targeted therapies in cancer and neurological disorders. The company differentiates itself through a focused portfolio in niche therapeutic areas, growth via strategic acquisitions, and a long-standing family heritage that shaped its international expansion and IPO-driven capital for expansion. Its goal is to address unmet medical needs worldwide by providing effective therapies for patients with serious or rare conditions.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Boulogne-Billancourt, France
Founded
2005

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