We are recruiting for a Senior Pharmacovigilance Specialist to join an established Pharmaceutical company in Hertfordshire, UK.
In this Senior Pharmacovigilance Specialist role you will be responsible for case management activities for Post marketing and Investigational products.
In the absence of the Pharmacovigilance Country Lead, you will be responsible for overseeing and managing the day-to-day activities of the local countryoperations Pharmacovigilance Department.
- Translate and process spontaneous and solicited / clinical trial adverse events reports from their country/territories and enter them into the Global Safety database or forward to a designated data entry centre or contractual partners
- Conduct reconciliation of adverse events reports received from other company operating units and contractual partners, as applicable
- Submit, as applicable, spontaneous and solicited / clinical trial individual case safety reports (ICSRs) from their country/territories to the local Health Authorities
- File, store, and archive safety-related data
- Serves as back-up coverage in the absence of the Pharmacovigilance Country Lead to ensure business continuity
- Serves as the local Deputy Qualified Person for PV for their country in the absence of the local Qualified Person for PV when delegated
- Comply with PV regulations and Global Safety policies/procedures and when needed take corrective action
- Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for late reporting within their country/territory
- Prepare for audits/inspections for their country/territories and participates in the audit and/or inspection
- Identify and communicate potential safety issues
- Deliver training to PV staff and customer facing non-PV staff and distributors
- Train and mentor PV staff
- Complete and document required PV training within required timelines
- Serve as the point of contact for the local Health Authority or liaise with the Global Regulatory Affairs (GRA) / Global Medical Affairs (GMA) colleagues for questions from the Health Authorities regarding safety and ICSRs in absence of the Pharmacovigilance Country Lead
- Liaise with the Country Leaders and colleagues in Global Clinical Trial Operations (GCTO), Global Regulatory Affairs (GRA), Global Medical Affairs (GMA) and other business units to ensureprocesses are in place for activities that are performed by those functions which impact PV
- Liaise with the EU QP PV in consultation with Global Safety Regional Leader or Global Safety MoW / EU – Leader in the absence of the Pharmacovigilance Country Lead
- Liaise with PV Regional Centres/Data Management Centres
- Participate on corporate sponsored committees and councils in the absence of the Pharmacovigilance Country Lead
- Represent the company at external safety meetings
Qualifications & Experience
- The incumbent must have a health, life science, or medical science degree or equivalent by experience and be fluent in English while proficient in local language.
- He/she should have proven industry experience in pharmacovigilance.
- The Senior Pharmacovigilance Specialist must have extensive knowledge of Pharmacovigilance regulations in their country/territory.
- He/She is expected to have strong communication and time management skills and have the ability to work independently with minimal supervision.
For more information or to apply for this Senior Pharmacovigilance Specialist position, please contact Hendre Moolman at CK Clinical on 01438 743 047 or email email@example.com
Entitlement to work in the EEA is essential. Please quote reference CL21224 in all correspondence.