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).
