Hendre Moolman is recruiting for a Senior PV Operations Manager to join a biopharmaceutical company in the pharmaceutical industry at their site based in Oxford on a 3 day per week 12 month contract.
The main purpose of the role will be to
- Provide Pharmacovigilance support and advice on pharmacovigilance processes, including SOPs, AE report management, QC, compliance, reconciliation, audits and inspections
- Assist with compliance monitoring and oversight of pharmacovigilance vendor
- Provide oversight of Safety Data Exchange Agreements (SDEA's) with third parties
Further responsibilities will include:
- Working in close collaboration with Medical Monitor, Clinical Operations, Regulatory and other functional departments
- Coordinating and inputting of al DSUR's, SAE reporting procedures, trend analyses, signal detection, and AE coding
- Process and maintenance of medical device reporting requirements
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- BSc or equivalent
- Proven Clinical trial drug safety expertise
- Hands-on expertise in DSURs and IBs production and management of Reference Safety Information.
This is an excellent opportunity to join a stable team working on very unique projects
Benefits include a competitive rate, 1 day remote working and long term 12 month contract
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 CL39632 in all correspondence.
You must be eligible to work in the UK. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 28th July 2017
- Expires: 25th August 2017
- Reference: CL39632