Pharmacovigilance (PVG) Project Leader

Bionical Emas

  • Derby
  • Permanent
  • Full-time
  • 19 hours ago
A Career with PurposeBionical 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.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
What will you need to succeed?
  • Bachelor's degree in a relevant field
  • Previous pharmacovigilance experience in PV project management or an equivalent role
  • Strong knowledge of EU GVP legislation and guidance
  • Experience of post-marketing PV regulations
What will you get in return?We want you to do your best work! We care about our people's well-being, their personal development and providing a true work-life balance. Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.
  • 25 days of vacation
  • Vacation days purchasing scheme
  • 1 extra vacation day per each 3 years of service
  • Discretionary Annual Bonus
  • Sabbatical of 3 to 6 months (after 2 years of service)
  • Free food and beverages at all offices
  • Life Insurance
  • Health Insurance and Employee Assistance Programme
  • Employee Support Networks - help us continue to build on our inclusive culture
  • Flexible and hybrid work
Does this sound like you?It is time to apply, and we can't wait to hear from you!Even if you don't meet 100% of the requirements, be confident in yourself and don't hesitate to apply!PLEASE NOTE: We will be longlisting applications as soon as we receive them, so please apply early to register your interest.We Are Bionical EmasWe are proud of our people and proud of our achievements. We encourage and hire people with diverse backgrounds, voices, beliefs, and perspectives into our growing global workforce. We do not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state or local laws and ordinances. Bionical Emas' management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.Bionical Emas offers equal opportunities and is committed to diversity in its workplace and providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with Bionical Emas and need accommodation or special assistance, please let us know by sending an email with your request to the recruitment team at .We Are Bionical Emas, where each person is unique. We celebrate individuality while encouraging our talents to work as a team. Together, we make a difference by powering an inclusive future for all. Be you, with us.Protecting your privacy and the security of your data is a longstanding top priority for us. Please consult our Privacy Notice to know more about how we collect, use, and transfer the personal data of our candidates. Our Privacy Notice explains what personal information we may process, where we may process your personal information, our purposes for processing your personal information, and the rights you can exercise over Bionical Emas' use of your personal information. By applying for the above position, you confirm that you have reviewed and agreed to our Data Privacy Notice for Candidates: applicable to your place of residence.Powering the patient journey

Bionical Emas