Safety Evaluation and Risk Management
An attractive job opportunity has arisen at a leading multinational pharmaceutical company who is seeking a Safety Evaluation and Risk Management Director (SERM) to work at their UK site. The company employs 100,000 personnel across 150 countries, working across multiple therapy areas including cardiovascular, oncology, and respiratory.
- Leads thinking in CH SERM around risk management plans and their implementation.
- Prepares the regional Risk Management Plans for designated products for submission to regulatory authorities
- Delivers the clinical safety input into clinical development planning activities
- Reviews and provides technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters.
- May be responsible for the signal detection and evaluation process of certain products within the SERM team, as delegated by the PV Team Leader.
- Produces regulatory supporting documentation for labelling updates
- In consultation with the product physician and Clinical Development representatives, prepares the Development Core Safety Information (DCSI) for assigned development products
- Drives production of periodic regulatory documents (PSURs, DSURs) according to the agreed process and timelines.
- Leads the SERM safety component of global regulatory submissions for new products, formulations or indications, with liaison with other functional experts
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- Trains, coaches and mentors' scientists in the scientific aspects of signal evaluation methodology and risk management and preparation of safety reports and other documents
Skills and Qualifications
- Degree in Biomedical or Health Care related speciality
- Expert evaluation skills and analytical thinking
- In depth knowledge of clinical development process
In case you have difficulty in applying or if you have any questions, please contact Tom Russell on +44 203 8246 104 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.