- Experience Level
- Experienced (non-manager)
Hobson Prior has partnered up with a very patient-focused R&D-driven biopharmaceutical organisation who are in search for a PV Associate to join them on a 3 month contract basis in London.
Please note that to be considered for this role you must have the right to work in this location.
- Support PVAR Country Head with maintenance of the PV system in the LOC which includes, but is not limited to maintain compliance to all applicable Global PV processes and commercial team engagements; PSP, MRP, agreements etc. This includes working with PV suppliers, where appropriate and ensuring a common understanding of the distribution of PV responsibilities is in place.
- Assist in the preparation of PV training material, ensure planning and implementation of appropriate PV training to sales representative, customer service, HCP and others as appropriate.
- Support with the preparation of a local RMP, if required and discuss with RA specific requirements by the National Regulatory Authority, Liaise with local RA team to address additional requests from the NRA and coordinate implementation of the Risk Minimisation Activities in the country.
- Work with PVAR Country Head and Vendor oversight Lead and the relevant QA team to support in vendor oversight to ensure contracted PV activities meet expected quality and are completed timely.
- Contribute to or be responsible for the safety documents preparation. Documents include but are not limited to UK/EU PSMF related documents, country specific risk management plan, PSUR, the LOC specific safety reports.
- Ensure the regular communications to the LOC is maintained in timely manner (Mailbox Monitoring) and provide the relevant information to the PVAR Country Head/NCPPV.
- Support PVAR Country Head and work alongside other PVAR/GPSE colleagues to implement global, regional and local PV strategies at the LOC.
- Support local PV suppliers as required including establishing appropriate oversight of such suppliers, if applicable.
- Ensures all contact information and any changes of LOC PV personnel are communicated for GPV communications.
- Ensures appropriate document repository is updated accordingly to correctly reflect changes in agreements, RMP, PSUR, ICSR compliance records and initiation of a Change Control Procedure where needed.
- Embrace the cultural mind-set of "Patient, Trust, Reputation and Business" in the workplace, undertaking personal accountability to live these values as we work within our one GPSE worldwide team and represent our GPSE function inside and outside of the company, as appropriate.
- Excellent written/oral communication skills (local language and English) with proven ability to negotiate and communicate with internal and external stakeholders.
- Accuracy and attention to detail with flexible mindset.
- Team worker with collaborative approach.
- Ability to priorities under pressure.
- Well-developed organizational skills.
- High standard of computer literacy.
- Bachelor's level degree or above in life sciences, pharmacy, nursing or medical. Advanced degree preferred.
- 2-years or more PV working experience in the pharmaceutical or CRO industry, have a deep understanding of pharmacovigilance and local regulatory requirements & processes for the post marketing global environment.
- Understanding of medical/scientific terminology.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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