Senior Pharmacovigilance (PV) Specialist - Киев - вакансия 968270


Дата: 10.06.2021

Город: Киев

Сфера деятельности: Медицина и фармацевтика

Текст вакансии:

The Senior Pharmacovigilance (PV) Specialist is responsible for the day-to-day coordination of activities, related to the safety aspects of Abbott pharmaceutical products within the country(ies) covered by the country operation including compliance with PV processes and regulations and company policies and procedures. Responsibilities: Qualified PV coverage and processes for back-up coverage (including coverage outside of business hours); Monitoring of Affiliate PV system performance and compliance, and resolving of nonconformities; PV training of the Affiliate staff and contractual partners; PV business continuity planning and notification of any incidents that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance; Handling of internal PV audits and inspections from regulatory authorities; Individual Case Safety Report (ICSR) management and ICSRs received within the country(ies) covered by the country operation (receipt, documentation, tracking, expedited reporting, etc); Collection of safety data and other PV-related responsibilities in relation to interventional studies (clinical trials); Collection of safety data and other PV-related responsibilities in relation to organized data collection schemes (non-interventional studies, registries, patient support programs, market research programs, etc.); Local screening of scientific literature and social media for safety information; Periodic safety reporting (scheduling, local submissions, documentation etc.); Handling of inquiries relating to product safety including regulatory authority inquiries; Reconciliation of adverse events reports received from other operating units (e.g. Medical Information, product complaints) and contractual partners, as applicable Oversight of the Risk Management Plan (RMP) Implementation. Contribute to preparation of local RMP and ensure oversight of its implementation Contribution to product labeling changes; Review and approval of the safety sections/wording and processes in local commercial agreements to ensure appropriate training and reporting processes in accordance with company policies and local regulatory authority requirements Consideration of PV matters during locally performed due diligence activities and negotiated contractual agreements, and exchange of safety information as defined in safety data exchange agreements; Safety signaling activities; Background Requirements: University degree in Medical, Pharmaceutical or Life Sciences Education. Expertise: Experience: at a minimum 2 years of pharmaceutical industry experience. Awareness of pharmacovigilance systems & requirements. Knowledge of the local country(ies) pharmacovigilance regulations & obligations. Strong communication and time management skills. Fluency in English, efficient Computer Skills. Excellent time management, organizational & planning skills. Strong project management skills with the ability to prioritize assignments. If you are interested in this opportunity, please do not hesitate to reach out and apply with your CV.

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