PV Specialist in Hoddesdon
Jenni is recruiting for a PV Specialist to join a company in the Pharmaceutical industry at their site based in Hoddesdon on a 6 month contract basis.
Position Purpose: The Pharmacovigilance (PV) Specialist is responsible for the day-to-day case management activities within the country(ies) covered by the country operation including compliance with PV processes and regulations and company policies and procedures. He/she is able to function independently in the processing of adverse events.This includes the procedural responsibilities in the areas of: Adverse experience case management including HA submissions; aggregate safety report health authority submissions and health authority submission compliance for individual case safety reports and aggregate safety reports. As requested by the PV Country Lead, the PV Specialist may undertake other additional activities including projects.
- Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per company procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.
- Responsible for the reconciliation of adverse events reports received from other business operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable.
- Responsible for the filing, storage and archiving of safety-related data in accordance with company policies and local requirements.
- Responsible for being compliant with local PV regulations, company policies and procedures and Global Safety procedures at the country level.
- Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.
- Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.
- Identify and communicate potential safety issues to PV Country Lead.- Assist in the delivery of training and mentoring PV staff as applicable.
- Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope.
- Complete and document required PV training within the required timelines.
- Perform other activities as requested by the PV Country Lead.
- Liaise with Data Management Centres and Global Safety Global Case Management colleagues at HQ.
- The incumbent must have a health, life science, or medical science degree or equivalent by education / experience.
- He/she should have at a minimum 1 year of pharmaceutical industry experience.
- He/she must have an awareness of Pharmacovigilance regulations within his/her assigned country(ies).
- The PV Specialist is expected to have strong communication and time management skills, and have the ability to work independently with minimal supervision.
- Awareness of pharmacovigilance systems & requirements.
- Awareness of pharmacovigilance principles, concepts, practices & standards.
- Knowledge of the local country(ies) pharmacovigilance regulations & obligations.
- Awareness of Good Clinical Practice concepts.
For more information or to apply for this position, please contact Jennifer Woolley on 01246 457733 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45624 in all correspondence.