Sr Director, Patient Safety

Job Description

Senior Director, Affiliate Safety Excellence

The Senior Director, Affiliate Safety Excellence is a vital strategic partner in advancing global pharmacovigilance excellence. Reporting to the Executive Director, Patient Safety, this role plays a pivotal part in shaping the future of patient safety through cross-regional integration, innovative strategies, , and cross functional & external engagement. By fostering strong partnerships across global and affiliate teams, and driving forward-looking initiatives, the Senior Director ensures that safety practices and data analysis remain agile, aligned and patient-centered across geographies.

Key Responsibilities:

Regional Strategy & Global-Affiliate Integration

• Develop and implement strategic frameworks to guide regional safety experts, QPPVs and Affiliate Heads of Patient Safety in product safety oversight in their regions.

• Provide integration and learning of product safety profiles via collaboration between Patient Safety Therapeutic Teams and affiliate teams, ensuring bidirectional communication and strategic alignment.

• Facilitate co-creation of best practices and harmonized safety processes across regions.

External Landscape Monitoring & Strategic Foresight

• Contribute to horizon scanning across health authorities, industry trends, emerging technologies, and societal shifts that influence pharmacovigilance.

• Help translate external intelligence into meaningful insights that inform global safety strategy and foster innovation.

• Support representation of the organisation in external forums, regulatory roundtables, and industry collaborations, sharing perspectives and learning from others.

· Act as a global ambassador and thought leader, proactively influencing regulatory evolution and industry, including EU and global regulations through participation in the PV Regulatory Intelligence Core Team and external forums such as IFPMA, helping shape discussions and build collective understanding.

Safety Health Literacy & Insight Safety Strategy

• Provide expertise and guidance into the development of health literacy strategies that enhance patient understanding and engagement with safety information.

• Collaborate cross functionally to embed health literacy principles into safety communications, labeling, and risk mitigation strategies.

• Generate insights from patient experience, behavioral science, and communication research to inform safety practices.

• Provide strategy for patient perspective and literacy testing strategies aligned with GVP Module XVI Revision 3.

Operational Excellence & Innovation

• Promote continuous improvement initiatives across safety that have an impact on affiliates

• Promote innovation across tools, processes, and strategic foresight to future-proof pharmacovigilance capabilities across the Affiliate network.

Regulatory Insight Leadership

• Leverage prior regulatory experience to anticipate agency expectations and shape internal safety strategies.

• Partner with Affiliate Heads of Safety and wider Patient Safety and cross functional teams to ensure alignment between safety strategy and evolving regulatory frameworks.

Provide interpretation of complex and evolving regulatory guidance, translating implications into action to ensure appropriate risk management strategies via cross PS and cross functional collaboration.

Qualifications

• Advanced degree in life sciences, pharmacy, medicine, or public health.

• 12+ years of experience in pharmacovigilance, drug safety, or regulatory affairs, with global and regional exposure.

• Proven leadership in external engagement, strategic planning, and cross-functional collaboration.

• Expertise in health literacy, patient engagement, or safety communication is highly desirable.

• Strong analytical, communication, and stakeholder management skills.

• Previous experience as health regulator preferred.