Pharmacovigilance Specialist

Our client, a multinational pharmaceutical company, is looking for a pharmacovigilance professional with pharmaceutical industry experience, awareness of Pharmacovigilance regulations, strong communication and time management skills, and have the ability to work independently with minimal supervision. Responsibilities: The Pharmacovigilance (PV) Specialist is responsible for the day-to-day case management activities including compliance with PV processes and regulations. Able to function independently in the processing of adverse events. This includes the procedural responsibilities in the areas of: · Adverse experience case management including Health Authority submissions. · Aggregate safety report health authority submissions and health authority submission compliance for individual case safety reports and aggregate safety reports. · The PV Specialist may undertake other additional activities including projects. Key Activities: o Responsible for day-to-day adverse experience case management including case intake and follow-up activities in accordance with Global Safety procedures, o The review of local literature and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements. o Responsible for the reconciliation of adverse events reports received o Responsible for the filing, storage and archiving of safety-related data o Responsible for being compliant with local PV regulations and Global Safety procedures at the country level. o Participate in individual case safety report compliance activities and takes the necessary corrective actions. o Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection. o Identify and communicate potential safety issues to PV Country Lead. o Assist in the training and mentoring of PV staff as applicable. Complete and document required PV training within the required timelines. o Perform other activities as requested by the PV Country Lead. Requirements: - Health, life science, or medical science degree or equivalent by education / experience. Please apply online or contact Crina Banarescu at Ark Talent Group for further information. This job was originally posted as www.totaljobs.com/job/89707172