Senior Pharmacovigilance specialist
полная занятостьПо договорённости
Senior Pharmacovigilance specialist acts as back-up for the Pharmacovigilance Country Lead. Main responsibilities are case management activities including compliance with pharmacovigilance (PV) processes and regulations and Sponsor policies and procedures. This includes the procedural responsibilities in the areas of: adverse experience case management including regulatory submissions; aggregate safety report health authority submissions and health authority submission compliance for individual case safety reports and aggregate safety reports. In the absence of the PV Country Lead, he/she is responsible for overseeing and managing the day-to-day activities of the local country operations Pharmacovigilance Department.
Principle responsibilities include:
• Case intake and follow-up activities in accordance with Sponsor procedures, the review of local literature as per Sponsor’s procedure and country regulations, and health authority submissions of cases in accordance with Sponsor procedures and health authority requirements.
• Aggregation of safety report submissions in the country (ies) in accordance with Sponsor procedures and health authority requirements.
• Reconciliation of adverse events reports received from other Sponsor operating units and contractual partners, as applicable
• Filing, storage and archiving of safety-related data in accordance with Sponsor policies and local requirements.
• Serve as the local deputy qualified person for PV / deputy local responsible PV person for the country (ies), if required.
• Participation in individual case safety report compliance activities and implementation of the necessary corrective actions locally for the late reporting within the country (ies) covered by the country operation.
• Preparation for audits/inspections for their country/territories and participation in the audit and/or inspection.
• Identification and communication of potential safety issues to responsible person.
• Delivery of training to PV staff and customer facing non-PV staff and distributors / vendors / business partners in the country (ies) within scope.
• Completion and documentation of required PV training within the required timelines.
• Training and mentoring PV staff, if applicable
• Responsible for reviewing local initiatives, patient programs (including patient support programs), local non-interventional studies for compliance with PV requirements as applicable
• In the absence of PV Lead liaise with the Country Leaders and colleagues in Global Clinical Trial Operations (GCTO), Regulatory Affairs (RA), Medical Affairs (MA) and other business units to ensure processes are in place for activities that are performed by those functions that impact PV
• Responsible for delivery, documentation and tracking of completion of training to PV staff and customer-facing non-PV staff (e.g. Sales Representatives, MA, RA and etc.) and vendors involved in PV activities
• Other activities as requested by the immediate supervisor.
Deep knowledge of regulation in the field of pharmacovigilance, knowledge of Russian, EAEU and international requirements. Knowledge of processes related to pharmacovigilance system master file (PSMF), risk monitoring plan, risk minimization management. Ability to interact with regulatory authorities.
International company is looking for a Senior pharmacovigilance specialist. We offer interesting and challenging job in the global pharmaceutical environment, potential for development and competitive remuneration.