職位描述
職位描述：
崗位職責:
Location: Nanjing, China
Provides strategic leadership and oversight for the pharmacovigilance and drug safety function of the company. Ensures proactive and timely risk-benefit assessments of safety data to characterize the emerging and known safety profiles of all products. Ensures successful implementation, execution and maintenance of safety-related strategies, processes and systems that conform to the company’s business strategy, industry standards and compliance with regulations.
Responsibilities
? Effectively manages the drug safety function to ensure that safety reports received from clinical trials (and post-marketing) are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.
? Provides medical expertise in the review and analysis of clinical study safety information.
? Participates in the review of individual SAE reports, prepares medical commentary and analysis, and in the preparation of safety evaluations in aggregate periodic reports.
? Ensures accurate medical coding (MedDRA and WHO-DD) of safety data
? Represents the Pharmacovigilance &Drug Safety department in safety-related discussions with clinical investigators, IRBs/ECs, Data Monitoring Committees and regulatory authorities.
? Protects study subject safety by contributing to the ongoing risk/benefit analysis of investigational drugs in clinical development.
? Prepares and maintains departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products.
? Participates in health authority interactions (both written and verbal) and inspections regarding safety and risk management
? Participates in due diligence teams to evaluate new potential in-licensing and out-licensing opportunities.
? Provides supervision, leadership and professional development to members of the pharmacovigilance department
任職資格:
? M.D. (or equivalent), with at least 5 years relevant pharmaceutical industry experience in pharmacovigilance/ drug safety
? Advanced knowledge of safety regulations, Good Clinical Practices, principles of drug development and safety assessment of investigational drugs
? Strong leadership and team management skills
? Excellent verbal and written communication skills, including formal presentation skills
? Experience in developing and implementing risk management strategies and plans
? Demonstrated experience in strategic and multi-project planning
