R&D
Là où votre curiosité fait avancer les miracles de la science

Job title: Country Safety Head Back-up / PV Officer, Greece & Cyprus

• Location: Athens, Greece
• Job type: Permanent, full-time
• Flexible working: Hybrid (3 days in the office, 2 days home office)

About the job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

Join our Patient Safety and Pharmacovigilance (PSPV) department as Country Safety Head (CSH) Back-up/PV Officer for Greece & Cyprus, member of the PSPV Central and South Europe Multi-Country Organisation (MCO), and you’ll play a key role in championing Patient Safety by enabling Sanofi to optimise the benefit-risk of our therapies, so we can best serve our patients.

Ready to get started?

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main responsibilities:

The Country Safety Head back-up/PV Officer supports the Country Safety Head for Greece & Cyprus to ensure that local PV activities are performed in compliance with the global/regional/local PV regulations and PSPV Quality Documents to warrant safe and appropriate use of Sanofi products in Greece & Cyprus. In this role, the CSH back-up/PV Officer:

• Replaces the CSH in most of his/her tasks when he/she is out of the office, including acting as local PV contact for the authorities and being accountable for PV inspections
• In collaboration with the CSH, maintain robust collaboration/interaction with the global & in-country partner functions, to carry out and monitor local PV activities, in compliance with PV regulatory requirements and company procedures/guidelines
• Monitor continuously incoming communication to ensure the detection and appropriate management of incoming PV data to report them in a timely manner to PSPV/Global PV entities and external stakeholders, such as HAs or partners
• Ensure appropriate screening of local scientific/medical literature and process the relevant abstracts/articles accordingly
• Ensure appropriate implementation and monitoring of PV requirements for global, regional and local programs (e.g. Patient Program, Market Research, Managed Access Program...), and company-sponsored digital media
• Screen and analyse national regulations, and forward any future/new/updated PV regulations to PSPV
• Participate in the local business continuity plan and after hours’ emergency calls process
• Ensure accurate local implementation of global Safety Data Exchange Agreements (SDEAs)
• Secure that for all local Business Partner agreements requiring safety provisions, a local SDEA or PV clause is set up, implemented and maintained as appropriate
• Contribute to the development of the local implementation plan of additional Risk Minimisation Measures (aRMMs) and enable its implementation by working cross-functionally with Country GBU Medical Head (or delegate), the Country Regulatory Manager and other appropriate functions
• Establish and implement processes in compliance with regional/local PV regulations and global Sanofi group procedures, and cooperate with the Country Quality Head (CQH) to document them in local Quality Documents as appropriate
• Develop and maintain the local Pharmacovigilance System File (LPSF) or the local Pharmacovigilance System Description (LPSD) in accordance with the global standards and local legislation
• Ensure that education and training on PV and relevant safety topics within the local organisation are performed, including the documentation of attendees and topics covered
• Manage local compliance metrics generation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and related tracking activities
• Warrant inspection readiness of the local PV system with key stakeholders (i.e. Quality, Medical and Regulatory)
• Complete in timely manner, audit and inspection observations, CAPAs in close interaction with Global/Local Functions
• In case of local outsourcing of PV activities to third parties (i.e. vendors/service providers/CROs), manage contract/work order with local service provider, monitor the appropriate execution of outsourced activities and take the appropriate measures in case of deviations

About you

• Experience:
  • A minimum of 2-3 years of experience in pharmacovigilance, preferably at multinational setting
  • Experience on required standards for high-quality safety-relevant documents, e.g. RMP, PBRER, is a plus
  • Experience with Regulatory Agency interactions

• Soft and technical skills:
  • Leadership, able to create networks and to collaborate in an international cross-functional environment
  • Interpersonal skills of diplomacy and team player dynamics, knowledge of and respect for cultural differences, professionalism and mediation are important
  • Demonstrate problem-solving skills, sense of urgency, especially with respect to enforcing safety rules and global procedures as described in QDs, Operational Manuals and Guidance documents. Capacity to work under pressure
  • Ability to work in international and transversal teams
  • Robust knowledge of pharmacovigilance systems & regulations
  • Sufficient ability to interpret clinical data, including safety data
  • Able to evaluate & manage safety signals and define risk management activities

• Education:
  • Minimum: Degree in Medicine / Pharmacy / Health Sciences or equivalent.
  • Preferred: Master’s degree in a healthcare-related field.

• Languages:
  • Fluency in written and spoken English is essential

Why choose us?

• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.
• Enjoy opportunities to collaborate beyond your area of expertise, working with diverse teams across science, clinical, and digital fields to spark new ideas and drive breakthroughs.
• Accelerate your professional development with structured career paths designed for both scientific and leadership advancement. Grow in ways you never imagined through bold moves that stretch your potential, cross moves into other business areas, and short-term gigs that build your scientific expertise.
• Join a workplace where diversity, equity, and inclusion are at the core, with Employee Resource Groups and leadership programs that celebrate every voice.
• Achieve genuine work-life balance in a supportive R&D environment.
• Enjoy outstanding benefits, including flexible working options, comprehensive healthcare, and well-being programs designed to help you thrive.

#LI-EU

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