компания "antal russia" innovative pharmaceutical company is looking for a specialist in the moscow pharmacovigilance hub. responsiibilities: i. maintain a local pv system in context with and as defined in the wider global pv system ensure appropriate documentation of pv related information and activities ensure business continuity of critical pv systems, processes, and activities ensure pv inspection readiness at all times ii. pharmacovigilance system master file where pv hub is required to provide information and data relevant to the global psmf, or for other global pv oversight or management purposes, ensure the data is current, accurate, complete, and provided in a timely manner where a separate local psmf is required, ensure consistency with global processes for local psmf or pssf iii. individual case safety reports ensure oversight and management of icsrs from all sources in a timely manner, including appropriate follow up, reporting, and documentation the above also applies to external third parties acting on behalf of company iv. management of aggregate reports ensure relevant information is provided to global functions for the preparation of aggregate reports v. risk management and safety communication contribute to the development of local risk management plans and ensure oversight of rmp implementation and safety communication, including adequate documentation of risk minimization activities, dissemination of communication and activities, decisions, and actions taken as applicable vi. oversight of studies, programs, and other business activities ensure appropriate safety reporting and oversight processes are in place for studies, market research and patient support programs, pre-approval and post-trial access programs, and all other business activities with implications for pv compliance ensure oversight of external third parties acting on behalf of company or acting as company business partners. this also includes written documentation of roles and responsibilities relating to pv compliance, and oversight of adherence to agreed roles and responsibilities requirements: education/qualifications minimum: health care professional degree (e.g. medical degree, pharmacist,) or life science degree (e.g. bsc biology, bsc neuroscience, etc.) experience, skills, knowledge: appropriate experience in drug safety/pharmacovigilance, preferably 1-2 years knowledge of global pharmacovigilance regulatory requirements ability to evaluate, analyze and interpret data, and draw conclusions, independently strong organization skills effective team player good interpersonal skills, builds strong sustainable and collaborative relationships with internal and external stakeholders good communication skills, both written and verbal creative problem solving in a complex process-focused environment ability to work under pressure and convey a sense of urgency ability to work across cultures, including in a virtual environment computer literate technical and business expertise, communication, teamwork and collaboration, achieving results english - upper-intermediate сonditions: competitive salary life and health insurance mobile phone allowance meal allowance annual bonus
Адрес
Москва