Global Safety Medical Manager
CK Group are recruiting for a Global Safety Medical Manager to join a biopharmaceutical company at their site based in Uxbridge on a contract basis for 12 months. Remote working will be considered for this role.
Salary: Up to £56.77 (PAYE) / £75.34 (Umbrella) – role is inside IR35
Global Safety Medical Manager Role:
- Search and review adverse event data, literature, and other safety-relevant data for the purpose of signal detection.
- Author Safety Assessment Reports and othersafety documents and regulatory responses in collaboration with the Global Safety Officer (GSO).
- Prepare presentation of Team’s recommendations on safety issues and assist in the development of risk management strategy and activities.
- Supportactivities related to new drug applications and other regulatory filings.
- Provide support for clinical trials to review and provide input to study-related documents
- Undertake activities delegated by the Qualified Person for Pharmacovigilance (QPPV) as detailed in the Pharmacovigilance (PV) System Master File and maintain a state of inspection readiness.
Your Background: Basic Qualifications:
- Doctorate degree and 2 years of directly related experience OR
- Master’s degree and 6years directly related experience OR
- Bachelor’s degree and 8 years of directly related experience
- RN, PharmD, MPH or PA
- Three to five years direct experience in pharmacovigilance: signal detection and evaluation; data analysis interpretation and synthesis; periodic report production
- Knowledge of processes and regulations for pharmacovigilance and risk management
- Clinical/medical research experience
Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.
This Global Safety Medical Manager role will be based at our clients site in Uxbridge but the client will also consider candidates who prefer to work remotely.
For more information, please contact Heather Deagle on 01438 870011 or email email@example.com. Please quote reference 51683. It is essential that applicants hold entitlement to work in the UK.