Description

• Detect, collect, record, translate, book in AEs or other safety information from all sources (for drug and medical device) and notify Central Safety Unit (CSU) in a timely and complete manner.
• Perform monthly reconciliation with GMS Compliance Team to ensure compliance to regulatory regulations and GEHC policy.
• Perform medical or scientific literature in local language are reviewed to identify possible adverse events or special situations reportable to CSU in timely manner.
• Support the review, localization, and submission of aggregate reports to ensure compliant to relevant regulatory requirements.
• Filing safety related information and other LSU documents (e.g. CV, JD, training log, org-chart etc.) according to local regulatory requirement and company SOPs
• Support the preparation and renewal of safety agreements (SIEA/SDEA) and ensure local safety reports are forwarded to partners according to the agreements.
• Provide PV/MDE trainings to local staff, new hiring, distributors, or 3rd party contractors to enhance awareness of their reporting responsibility.
• Support the management of local PV/MDE SOPs/ Work Instructions and China PSMF with high quality.
• Assist in audits and inspections.
• Maintain effective connection with internal and external stake holders to collect insight and promote PV value.
• Support the regulatory affairs (RA) department, quality assurance (QA) department and other relevant functional departments on PV/MDE related content or safety related enquiries.
• Provide prompt response to local health authorities (HA) for PV/MDE related request or queries, and support projects or activities of engaging local HA.
• Monitoring local PV/MDE regulatory requirement updates and support the conduct of gap analysis.
• Support safety management from clinical trials include but not limited to review contracts, protocols and Investigator Brochures, Safety Management Plan, DSURs and other PV related documents upon request.
• Attend high value PV/MDE related conference or training program.
• Covers for the PV/MDE Responsible Person during absence or leaves.
• Any other tasks assigned by PV/MDE Responsible Person (this could include collaboration, communication and cross functional working opportunities within GPV team).

Qualifications

• Bachelor’s degree or above, major in medical, pharmaceutical, epidemiological, or related.
• At least 3 years of pharmaceutical/biotechnology industry experience in pharmacovigilance.
• Up-to-date knowledge of current China regulations and industry guidelines governing pharmacovigilance.
• Competent oral and written English.
• Excellent interpersonal, oral, and written communication skills to a range of internal and external customers
• Skilled in Microsoft Office applications (Word, PowerPoint, Excel).