Jenni Woolley is recruiting for a Drug Safety Manager to join a company in the Pharmaceutical industry at their site based in High Wycombe on a 9 month contract basis.
Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies - the largest diversified healthcare group in the world with over 100 years of scientific heritage. They employ approximately 500 people in the UK and Ireland. They are committed to delivering great medicines and have introduced a range of innovative treatments that can make an important difference to the lives of patients with serious health conditions such as schizophrenia, hepatitis C, multiple myeloma, HIV/AIDS and diabetes.
Working at their Headquarters in High Wycombe, the site is easily commutable. The nearest station is approximately 10 minutes by taxi. If you're travelling by car you can assess the site via the M40.
The Drug Safety Manager will carry out hands on Safety Management and Reporting, manage others and carry out general compliance activities. The successful candidate will have direct reports including Drug Safety Scientists, Drug Safety Assistants and Drug Safety Administrators.
Duties will include:
-Supervising the collection reviewing and reporting of Adverse Events (AEs) through spontaneous reports, clinical study reports, local literature, etc.
-Conducting initial quality review and assessments of local individual cases
-Writing, reviewing, validating and implementing SOPs/guidelines
-Co-ordinating the follow up of missing information in cases
-Providing local data to support the Preparation of Safety Summary Reports
-Manage the local PV/ Drug Safety team
-Work with EMEA PV to develop training plans
-Complete compliance metrics
-Sign off Targets
-Review effectiveness of CAPAs
To be a successful Drug Safety Manager you will have a proven background in Drug Safety / PV paired with a self-starting, organised, communicative personality. In addition, you should have the following skills, knowledge and experience:
-Proven ability to organise workflow activities and manage multiple issues
-Have an awareness of industry principles
-Knowledge of local and global SOPs
-Knowledge of GMS systems
-Prior role in a leading position
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference KA42791 in all correspondence
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Contact: Jennifer Woolley
- Phone: 01438 743047
- Reference: KA42791
- Posted: 12th July 2018
- Expires: 9th August 2018