Join our QPPV Office - PV Governance & Policy Leader (m/f/d) (1 year opport at F. Hoffmann-La Roche Ltd - Poland

Basel, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

26 Dec, 25

Salary

0.0

Posted On

27 Sep, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Regulatory Requirements, Strategic Thinking, Leadership, Communication Skills, Risk Management, Compliance, Project Management, Team Collaboration, Healthcare Knowledge, GVP Guidelines, EU Regulations, US Regulations, Organizational Skills, Decision Making, Agile Environment

Industry

Biotechnology Research

Description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position At Roche, patient safety is paramount. In a world of rapid scientific advances, technological innovations, and evolving regulatory requirements, you are the strategic compass that safely navigates our Pharmacovigilance (PV) system through complex waters. As the PV Governance and Policy Leader (m/f/d), you will provide PV expertise and leadership to support the EU QPPV’s oversight, upholding the trust placed in our PV system and in Roche’s commitment to patient safety. Your new Team You will join the QPPV Office team, a dynamic and pivotal unit within Product Development Safety Risk Management (PDS). Here, you will work closely with the QPPV Office Leadership Team and a network of qualified experts from diverse fields, as well as colleagues and stakeholders outside your direct authority. Your team consists of experienced colleagues who foster a culture of open dialogue, strategic foresight, and a focus on delivering meaningful outcomes. Together, you form an integral part of our PV system, ensuring that Roche consistently fulfills its responsibility to patient safety. The Opportunity As the PV Governance and Policy Leader (m/f/d), you will take on a key role where you can fully leverage your strategic and PV expertise: You proactively maintain oversight of PV compliance risks and trends, and provide strategic direction on the interpretation of regulatory requirements and their translation into company-wide positions and policies. You advise and enable the business on developing GVP-compliant solutions, ensure effective management of GVP governance meetings, and apply your strategic foresight to ensure our processes and decisions deliver both compliance and strategic value. As a key contributor to the EU QPPV’s oversight of product risk management strategies, you will review and provide critical input on key safety documents (e.g., EU-RMP, PASS, CDS). You play a key role in shaping clear and consistent communication with internal and external stakeholders, ensuring alignment with the position of the QPPV and the company’s vision. Who you are You are an experienced leader who combines strategic thinking with a pragmatic, outcome-focused mindset and are comfortable in navigating a highly regulated environment. Your foundation is a degree in a healthcare field (e.g., Medicine, Pharmacy, Nursing) or the Life Sciences. You bring extensive professional experience in pharmacovigilance and are familiar with the various facets of the PV system from hands-on practice. Your knowledge of EU and US regulatory requirements (GVP, ICH guidelines) is excellent. You have a proven track record of successfully leading global teams or strategic projects within a matrix organization and possess outstanding planning and organizational skills. As a strategic systems thinker, you thrive in a fast-paced, agile environment. You are results-oriented, make sound decisions, and know when escalation is appropriate. Thanks to your excellent communication skills in English (both written and verbal), you can convey complex topics confidently, professionally, and persuasively, even under pressure. Your contact to us! With people. For people. Do you need further support? Please have a look at our FAQs, you will find them via https://careers.roche.com/global/en/faq. Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

Responsibilities

The PV Governance and Policy Leader will maintain oversight of pharmacovigilance compliance risks and provide strategic direction on regulatory requirements. They will also advise on GVP-compliant solutions and contribute to product risk management strategies.