Hendre Moolman is recruiting for a Global Safety Manager to join a commercial, research & development biotechnology organisation at their site based in Cambridge on a contract basis for 12 months.
The main purpose of the role will be to:
- Take responsibility for ensuring adherence to company regulatory commitments for pharmacovigilance.
- Collaborate with other affiliate functions and also with Global Safety colleagues to meet business needs.
- Maintain awareness of current prescribing information (e.g.SmPC), safety profiles and new risk information for designated products, to support product safety activities.
Further responsibilities will include:
- Managing business core safety activities per legal deadlines including intake of AE reports, follow up with HCPs for complete data, ICSR & aggregate safety report submission to regulators.
- Collaborating with other affiliate departments including medical and commercial, to provide safety input into cross-functional initiatives (e.g. Patient Support Programs).
- Assisting safety team during audits and inspections of PV operations.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Graduate with life science or healthcare degree
- Proven relevant industry experience within pharmacovigilance
- You will have the ability to organise and maintain accurate records with attention to detail
- Experience with Safety Databases, particularly ARGUS, would be desirable.
This is an excellent opportunity to join a strong team, working across the UK and other affiliate offices
Benefits include a long term contract, working at a competitive rate
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 CL39732 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 1st August 2017
- Expires: 29th August 2017
- Reference: CL39732