+ Title: Senior Pharmacovigilance Officer and CSH Back-up (fixed term) + Location: Dublin, Ireland _About the job_ This role is responsible for the accurate and timely management of all assigned pharmacovigilance (PV) activities to contribute to an efficient pharmacovigilance system, supporting the evaluation of PV data and assisting the Country Safety Head (CSH)/PV Manager in managing workload. To ensure that the CSH/PV Manager is informed in a timely and accurate fashion of any potential safety, compliance, quality and regulatory issues. The position helps ensure local PV activities comply with global, regional, and local PV regulations to warrant the safe and appropriate use of Sanofi products in Ireland. At Sanofi, we chase the miracles of science to improve people’s lives. Every day we push the boundaries of what’s possible to help patients around the world. **Main responsibilities:** + Prioritize and manage individual and team workload + Oversee day‑to‑day processing of PV data within company and regulatory timelines + Completion of regular PV activities including Inbox monitoring, Follow up, aggregate reports, literature, Market research, patient programs, safety agreements, reconciliation, quality checks and local risk minimisation materials + Contribute to evaluation and follow up of safety data, responses to Health authority queries, review and analysis of any adverse event reporting trends + Preparation of PV related documents for internal/external use + Monitor safety data to spot trends or signals and escalate potential issues + Ensure that all processes and data are kept in an inspection and audit ready condition + Prepare local PV procedures, training materials and compliance reports + Support audits/inspections, corrective actions and vendor oversight + Assist with implementation of the quality management system within PV department + Maintain accurate and comprehensive hard copy and electronic documentation + Assist with PV training of local vendors including tracking + Ensure accurate and timely communication with local and global stakeholders + In absence of CSH/PV manager, review incoming data to identify any issues and action as needed + Replace CSH in tasks when he/she is out of office including acting as first point of contact for Health Authority queries + Interact and collaborate with PV local and global team as needed in the absence of the CSH _About you_ + Degree in life sciences or qualification as a health professional (e.g., pharmacy technician, pharmacist, nurse). + Substantial prior experience in drug safety, PV, quality, regulatory, pharmacy, nursing, or medical fields. + Experience with PV/GxP systems/databases and interaction with Health Authorities recommended. + Sound understanding of pharmacovigilance principles. + Strong attention to detail and good organisational, analytical, and time management skills. + Ability to recognise potential issues and propose solutions. + Excellent oral and written communication skills. + Good presentation skills. _Why choose us?_ + Work in a purpose‑driven global healthcare company improving millions of lives. + Enjoy hybrid working and a culture that values work–life balance. + Access a wide range of career development and learning programmes. + Join an inclusive, empowered team where your voice matters. + Collaborate with experts across Medical, Regulatory and Quality functions. + Contribute to a robust local PV system recognised for high compliance standards. **Pursue** _Progress_ . **Discover** _Extraordinary_ . Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Global Terms & Conditions and Data Privacy Statement (https://www.sanofi.com/en/careers/global-terms-and-conditions/) Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)