Pharmacovigilance Agreement Manager at Ipsen Manufacturing Ireland Ltd

Paris, Ile-de-France, France -

Full Time

Start Date

Immediate

Expiry Date

17 Dec, 25

Salary

0.0

Posted On

18 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Compliance, Audits, Inspections, Regulatory Authority, Partnerships, Risk Management, Subject Matter Expertise, Collaboration, Communication, Leadership, Continuous Improvement, Global Experience, Post-Marketing Legislation, Pre-Marketing Legislation, Stakeholder Management

Industry

Pharmaceutical Manufacturing

Description

Title:Pharmacovigilance Agreement Manager Company:Ipsen Pharma (SAS) About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. Job Description: Here at Ipsen we believe that patients cannot wait – for suitable treatment, for support, for awareness. We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases. The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives. We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing. The Pharmacovigilance (PV) Agreement Manager is leading the PV Partnering 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. Main Responsibilities: Drive the cross-functional process for ensuring that all commercial agreements involving pharmacovigilance commitments have the relevant terms of a Pharmacovigilance Agreement (PVA) based on the PVA template/PV partner category mapping For the Partner portfolio & Region the Manger PV Partnering is responsible for, Drive the oversight of commercial partners, as part of PV partnering governance meeting and structure. Lead and coordinate PVA/PV partnering meetings with commercial partners. Act as a key contributor to the PV partnering governance meeting and structure so as to ensure the right level of oversight on a risk-based approach for PV activities/responsibilities. Fully support any compliance activities, audits & inspections, as trusted subject matter expert. Support and being proactive in any compliance activities for audit and inspection readiness Serve as the primary source of subject-matter expertise to address any questions from Ipsen staff, from external partners regarding the processes concerning Pharmacovigilance Agreements, or any questions about PV partnerships and for driving best practice for continuous improvement In order to be considered for this role you must have: Strong global or regional pharmacovigilance experience within the pharmaceutical industry. Strong experience of working in pharmacovigilance or with pharmacovigilance agreements and partnering Prior experience with regulatory authority inspections and internal audits, either in industry, consulting, or health authority Good working knowledge of pre- and post-marketing PV legislation Fluency in English #LI-HYBRID Dans le cadre de ses recrutements IPSEN s’engage au respect de l’égalité de traitement des candidats, indépendamment du sexe, de l’âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat. At Ipsen, each employee makes a real impact. Our teams are passionate about what they do because they care about making a difference in patients’ lives. We invest in our employees to support life-changing projects that create positive impact for patients and society. Introduce yourself to our recruiters and we'll get in touch if there's a role that seems like a good match. Learn more about careers with us

Responsibilities

The Pharmacovigilance Agreement Manager leads the collaboration for pharmacovigilance agreements with commercial partners and ensures compliance with relevant legislation. They drive oversight of commercial partners and support compliance activities, audits, and inspections.