Medical Governance Manager
Life Science People are a strategic growth partner within the Life Science industry providing bespoke services to the life science community from SMEs through to blue chip organisations and sourcing the best talent to make a tangible contribution to healthcare.
Are you looking to work for an international biopharmaceutical company that are transforming the lives of patients with Rare Disease? Are you looking to give people living with rare disease access to innovative treatments while building out a new team? Then this is the role for you.
Reporting to the Medical Director, you will be managing Pharmacovigilance, Medical Information and Regulatory Affairs activities for the launches, as well as oversight of Medical Governance Function in the affiliate.
- Ensures local agreements (e.g. contracts with External Service Providers, PSP providers, Market Research providers) are compliant with regulatory PV requirements
- Ensures PV and MI induction training for UK affiliate employees is performed within timelines
- Performs compliance review of educational materials for patients
- Coordinates Product Information development/update in compliance with ABPI Code of Practice
- Develops Medical Governance strategy and represents Medical Governance in Medical Leadership Team and cross functionally
- Communicates with local Regulatory Authorities where required and acts as interface between UK QPPV and local Regulatory Authorities
- Works closely with Global functions (RA, PV and MI) to identify impact of global activities to UK and Ireland affiliate
- Reports adverse events to Global Pharmacovigilance, delegate/conduct follow up activities
- Acts as PSP owner for affiliate
- engagement with local roles within Medical Affairs, Commercial, Quality and Supply
- Develops new and existing SOP's for GxP activities to meet compliance standards and performs impact assessment of global GxP SOPs to ensure affiliate alignment
Key skills and requirements:
- Pharmacist or life sciences degree
- Excellent organisation skills
- Good team player and network builder, but also capable of managing tasks independently
- Experience in Pharmacovigilance from pharmaceutical or CRO background
- Highest levels of personal integrity, with a strong personal commitment to adhere to all rules, regulations, Standard Operating Procedures
- Experience in Medical Information is desirable
If this role interests you, then please apply now! You can submit your CV and cover letter highlighting your expertise as a Medical Governance Manager. Please note feedback can take up to 2-3weeks.
The interviews will take place as followed:
- 30-minute call with Hiring Manager
- Interview with Medical Director and acting Medical Governance Manager
- HR interview
The Medical Governance Manager role is a full-time permanent position, paying up a competitive salary & benefits package. Full details will be provided on application.