Drug Safety Manager - UK Affiliate

---

Job description

*Drug Safety Manager, UK Affiliate -Pharma - 6-month contract - Berkshire*

My client is a Global Biopharmaceutical company and they have a position available for a Drug Safety Manager for an initial 6- month contract.

Within this role the Drug Safety Manager is responsible for all local Pharmacovigilance-related activities for the UK and Ireland affiliate:

* Responsible for the overall provision of safety report handling relating to UKI
* Development and maintenance of local PV processes and procedures
* Training and tracking of all UKI and external providers on appropriate PV-related procedures
* Reviewing local and national legislation (MHRA or HPRA) to maintain an awareness of local regulations and ensuring local processes are aligned with these requirements
* Review of external provider reports for AEs, PCs, customer focus and most up to date information.
* Performing due diligence AE and safety report follow up as requested
* Tracking and reporting of safety reports from a variety of sources within specified timelines
* Reviewing local literature for safety-related content
* Monitoring the MHRA portal for safety reports
* Maintain an oversight of outsourced vendors with PV responsibilities
* Serve as the PV contact for local staff
* Assisting with regulatory requests or audits\/inspections
* Providing with monthly reports on PV metrics
* Documenting CAPAs and deviations related to PV deficiencies
* Performing local reconciliations with third party vendors
* Assisting with the follow up of PML cases
* Reviewing local market research material for compliance with legislation and codes of practice
* Reviewing vendor contracts for appropriate safety wording
* Assisting with audits of external third party vendors

In order to apply for the Drug Safety Manager contract, you should possess a Life science degree and have previous experience of working in the Pharmaceutical Industry within a Drug Safety \/ Pharmacovigilance arena. Excellent knowledge of Good PV practices is a must, knowledge of local PV regulations, CAPAs and experience of Vendor management \/ 3rd party. You should possess good written and verbal communication skills and strong IT skills and have the ability to work effectively both independently and as part of a team

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on .