SciPro have exclusively partnered with an innovative pharmaceutical company who are driven by their purpose to reimagine how drugs can improve the quality of life of patients with rare disease. They are a fast growing, agile organization transforming the lives of patients and care givers through the use of cutting-edge pharmaceutical technologies to translate pioneering science to medicine products.
We are supporting them on their search for a Senior Regulatory Affairs Associate within Pharmacovigilance. The successful candidate will join their Product Development Department and will be responsible for managing the day-to-day pharmacovigilance activities and lead on the development and improvement of the company's PV systems. This is an exciting time to join a small team, with exposure to multiple projects and the ability to impact the lives of patients whilst building on your own professional experience.
Key responsibilities:
- Drive process improvement of the PV processes including the maintenance of the PV system and Eu/UK PSMF
- Drive the preparation and review of PSURs, PADERs and RMPs
- Oversight of PV partners, creating and maintaining the external and internal audit plan
Key experience:
- Minimum 2+ years of experience within Medical Information and Pharmacovigilance role and a solid understanding of PV processes
- Good working knowledge of EMA GVP modules
- Experience with the FDA will be beneficial
- Knowledge of ICSR processing and SDEAs