Pharmacovigilance Associate - London | Zoek UK
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London, Greater London, England
Contract (Full time)
Collaborate and liaise with PVAR Country Head and other GPSE functions to support in the maintenance of appropriate systems/processes to support the local PV system
Pharmacovigilance operating support to the LOC where applicable
Manage the PV relationship within the local operating company (LOC) to provide best PV support for the LOC.
Support PVAR Country Lead to implement the local PV operation activities and strategies as appropriate to maintain compliance
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(NRA) (. conditional approvals), Liaise with local RA team to address additional requests from the NRA and coordinate implementation of the (additional) 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 the PVAR Country Head/NCPPV to maintain a local PSMF if required.
Support PVAR Country Head and work alongside other PVAR/GPSE colleagues to implement global, regional and local PV strategies at the LOC
Support internal and external PV audits or inspections.
Support local PV suppliers (. local resident QPPV suppliers, PV services suppliers (incl for business continuity) 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 company 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.
Education & Experience
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.
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.
Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert