Medical Governance Officer
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 into the Medical Governance Manager, you will be supporting new product launches, setting up PSP vendors and training multiple vendors. As a Medical Governance Officer, you will be handling medical information and product complaints, while monitoring the Medical Support mailbox.
Key responsibilities:
- Manages and maintains vendor oversight of outsourced GxP activities including contract management
- Performs Pharmacovigilance and Medical Information induction training to UK affiliate employees
- Coordinates Product Information development/update internally or by liaising with regulatory vendor
- Provides absence cover to the Medical Governance Manager
- Supports Medical Team in grant applications and other compliance related matters
- Liaises with Quality Manager to open and manage GxP deviations, CAPA's and change control.
- Assists Global Pharmacovigilance, when required, with the timely closing of findings related to PV inspection/PV audits at local level
- Responsible for PV related activities at local level
- Maintains MI system and associated data ensuring MI enquiries, Adverse Events and Product Complaints are correctly triaged
- Contributes to the development of Medical Governance strategy
Skills and experience required:
- Pharmacist or life sciences degree
- Experience with Medical Devices is desirable
- Experience in Medical information and/or PV from pharmaceutical or CRO background
- A willingness to learn
- Attention to detail, with excellent writing, analytical and problem‐solving skills
Recruitment process:
If this role interests you, then please apply now! You can submit your CV and cover letter highlighting your expertise as a Medical Governance Officer. 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 Officer role is a full-time permanent position, paying up a competitive salary & benefits package. Full details will be provided on application.
