Pharmacovigilance Associate LOC

Job Description

*Pharmacovigilance Associate - LOC - Top Pharma - 3-month initial contract * My client is a Global Pharmaceutical company and they have a position available for a Pharmacovigilance Associate to join their team for an initial 3- month contract. Within this role the Pharmacovigilance Associate will collaborate and liaise to support in the maintenance of appropriate systems/processes to support the local PV system and manage the PV relationship within the local operating company (LOC) to provide the best PV support for the LOC. You will also support 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, 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) (e.g. 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.* 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 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 colleagues to implement global, regional and local PV strategies at the LOC* Support internal and external PV audits or inspections.* Support local PV suppliers (e.g. 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.In order to apply for the Pharmacovigilance Associate contract, you should possess: * Bachelors level degree or above in life sciences, pharmacy, nursing or medical. Advanced degree preferred.* Pharmacovigilance 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 with proven ability to negotiate and communicate with internal and external stakeholders.* Accuracy and attention to detail with flexible mindsetBefore 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 . Required skills

Pharmacovigilance

LOC

PV

London

Vendor management

PV Processes

local operating company

PV Compliance

Contract PVAR

Keyskills :
Pharmacovigilance LOC PV London Vend management PV Processes local operating company PV Compliance Contract PVAR