PV Training Manager, EMEA
- Experience Level
- Experienced (non-manager)
This is an exciting opportunity to join a global pharmaceutical company as an Affiliate Support & PV Training Manager covering the whole of EMEA.
You will support the affiliate network of local safety offices in EMEA region. Report Directly into the Head of PV Operations and interacts regularly with Affiliates in EMEA region.
Main purpose of the job:
- To support the continuous improvement of pharmacovigilance skills within the PV team and EMEA region
- To identify pharmacovigilance skills gaps and training material requirements within the PV team and EMEA region
- Develop, implement and conduct appropriate training in pharmacovigilance and safety activities for EMEA affiliate Local Safety Officers
- Develop, implement and conduct appropriate training in pharmacovigilance and safety activities for EMEA PV partners in collaboration with PV Operations Scientist (Alliance Management)
- To maintain EMEA PV training matrix and liaise with L&D on e-learning assignments
- To lead and participate in other PV Operations initiated projects where required.
- To lead PV improvement efforts, EMEA PV led initiatives and cross functional projects.
- To provide leadership on PV Affiliate related matters during audits and inspections.
- To support the Head of PV Operations, Regional Safety Officer, General Safety Officers and Local Safety Officers in the EMEA region as required.
- Working with the network of Affiliate Local Safety Officers (LSOs) to ensure that safety information from all sources from the affiliate countries is collected and processed in accordance with company and regulatory requirements.
- Driving implementation and adherence for all aspects of affiliate PV related compliance, through risk identification, assessment and mitigation and sharing of best practices.
- To support the EMEA Regional Safety Officer and work with the network of Local Safety Officers to ensure effective PV processes and operations at an affiliate level.
- Liaise with the regional PV team and corporate PV audit department in the risk assessment of affiliates and co-ordination of PV audits at the affiliate; assist in the development of CAPAs in response to findings.
- To support Affiliate Safety staff in providing compliant, inspection-ready processes and the implementation of relevant updates to PV regulatory requirements.
- To develop monitoring programmes to ensure regulatory requirements for PV are complied with and any potential issues identified are communicated to stakeholders as necessary, e.g. to EMEA RSO/ EU QPPV.
- To establish and maintain a high level of familiarity with local, European, and international regulations and guidance relating to drug safety and pharmacovigilance and act as the main point of contact for the designated affiliate Local Safety Officers.
- To contribute to the day-to-day functioning of an effective regional and global drug safety network.
- Act as EMEA region PV trainer and support improvement in PV skills by identifying and assessing the training needs for EMEA region PV personnel and ensuring the delivery of relevant training accordingly.
- Liaise with PV Managers to assess the appropriate training for team members and as PV Departmental Training Coordinator ensure the PV training matrix and role-based training requirements are maintained. Create PV process/SOP training material and implement as appropriate.
- Develop, implement, and maintain PV training induction programme for EMEA region affiliate Local Safety Officers and support PV managers in the development of PV staff induction programmes and training.
- Develop, implement, and maintain and deliver PV training for EMEA region partners as required.
- Support the development of PV skills/ competency-based training curriculum and develop training programmes/ material as appropriate.
- Liaise with PV Managers to identify where non-compliance has occurred due to training issues and provide training as required.
- Support the development and implementation of any CAPAs related to PV training
- Co-ordinate and maintain the programme for initial and refresher training for other functions outside PV as required.
- Other ad hoc tasks as assigned by the Head of PV Operations/ Head of International PV.
- Author PV Controlled Documents where required.
- Office based in North London (once allowed to return to office)
ABOUT PLANET PHARMA
Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.
- If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 20 3928 8388 or e-mail on email@example.com
- If this role is not suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!
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