WHAT WILL YOUR JOB LOOK LIKE?

• Lead the establishment of client-specific pharmacovigilance systems, including safety management plans and data management plans
• Provide strategic advice on pharmacovigilance requirements to clients
• Represent PV in client meetings and act as the primary liaison for ongoing projects.
• Oversee project activities, contributing to delivery and invoicing accuracy
• Maintain and review SOPs, working instructions, and PV working tools such as safety databases and forms
• Prepare, coordinate, and review regulatory PV documents (DSUR, PSUR, PBRER, EU-RMP, PSMF, SDEA)
• Monitor evolving PV regulations, ensuring ongoing compliance and awareness.
• Contribute to client and company quality systems, including audits and CAPA/QE management
• Support SAE case management, including regulatory assessment and submissions to authorities
• Collaborate with clinical, scientific, and regulatory colleagues to provide integrated services

A CAREER WITH PURPOSE

Bionical Emas is a global Early Access Programs (EAP) and Clinical Trial Supply (CTS) group bringing life-changing medicines to patients around the world. Their range of services and capabilities benefit many of the world’s leading pharma and biotech companies.
At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success. If you are inspired by changing the lives of patients all over the world, we’d love to hear from you.

ABOUT THE ROLE

We are looking for a PVG Project Leader to set up and ensure delivery of effective pharmacovigilance (PV) support for client projects. This is a remote role reporting to the EVP, Medical Affairs.