Senior PV Associate
Slough - Berkshire
Up to 46,000 + 25 days' holiday, private medical, dental, pension, free on-site gym, shuttle bus
A new opportunity is available for a Senior PV Associate to join a global pharmaceutical company based close to Slough, Berkshire. Reporting directly to the PV & Med Info Manager, you will be working with the UK & Ireland affiliate to ensure that all PV processes and procedures are compliant with the smooth running of the UK PV function.
This is a full time, permanent vacancy with some home working flexibility. You will be working within a small PV team and this role requires someone with a strong work ethic, and a "can do" attitude. You will be rewarded with a fantastic working environment, a competitive salary and benefits.
- Handling of post-marketed ICSRs, of investigational SAE/non-serious pregnancy cases
and from sources including Patient Support Programs, Adverse device events and
- Ensure aggregate reports are submitted in a timely manner to the relevant recipients.
- Maintain electronic and /or paper file archiving system suitable for the storage of
source documents relating to drug safety, including audit of any third party responsible
at a local level for archiving PV documentation.
- Receipt and assessment of requests from medical information linked to ICSR/OEs and
quality/customer complaints for assessment and forwarding to GS /Medical
Information, as necessary
- Develop and maintain local QMS PV procedures
- Conducting training of PV processes' and systems to both internal and external
- Ensure audit findings CAPAS and deviation are actions and evaluated in accordance
- Participate in audits and inspections
- Notification to QPPV in case of any urgent safety issue and pharmacovigilance
- At least 3 years' relevant experience working in PV within a pharma or CRO
- Knowledge of global and local PV legislation and guidance
- Experience of training of PV processes to internal and external stakeholders
- Good IT skills
- Leadership skills desirable
- Life science degree required
If you are interested in this role, please call George on 0118 959 4990 or email your cv to email@example.com
- Agency: Clinical Professionals
- Contact: George Danchie
- Reference: JO-2007-452600
- Updated: 29th July 2020
- Expires: 26th August 2020