PV Operation (Sr.) Generalist

该职位来源于猎聘 Role & Responsibility -Coordinating and supervising all PV activities in clinical trials to ensure regulatory compliance, including but not limited to PV vendor management, contributing to preparation and submission of expedited safety reports, supporting preparation and review of safety related documents, collaborating on project issue identification and resolution. -Ensure collection and reporting of product safety events in post-marketing settings in good quality and in compliance with governing laws and legislations, e.g., spontaneously from HCP and consumers, literatures, product complaint, social media, regulatory authorities, organized data collection programs, etc. -Coordinate preparation and submission of aggregated safety reports, DSUR, PUSR/PEBRE, etc. -Contribute to identification, evaluation and management of safety signals in collaboration with Safety Physician /Scientist, Study Physician, Drug Safety colleagues and other applicable functional specialists. -Contribute to the development of safety surveillance and risk management plans for drug development programs. -Support internal and external PV audits or inspection. -Perform PV trainings to relevant personnel according to the safety activities assigned. -Contribute in negotiations with business partners on pharmacovigilance agreements; Interface with business partners as needed in accordance with applicable pharmacovigilance agreements. -Support PV head on the PV capability establishment, including but not limited to the PV procedure and SOPs establishment, etc. Requirement -Bachelor's level degree or above in life sciences, pharmacy, nursing or medical -Minimum 2 years experiences in safety operation -Familiar with PV processes and safety management in clinical study and/or post-marketing phase -Thorough understanding of the regulations and guidance applicable to PV -Prior international pharmaceutical company/CRO experience preferred -Experience in PV database management or audits/inspections is a plus -Excellent organizational skills, learning skills and ability to prioritize and multi-task -Excellent communication and interpersonal skills -Fluent in English (writing and speaking)