Position Summary:

This position contributes to PV activities for ongoing clinical trials and post marketing in international regions and China. Ensure PV activities to comply with company standards and fulfill China and other countries health authority requirements.

Key Responsibilities：

Provide medical safety support

 Provide medical review and quality control for individual safety cases

 Take safety responsibilities for pre/post marketing studies/IITs

 Regularly conduct literature searches and evaluations for Everest drugs to keep abreast of the latest product knowledge, especially safety-related information, and provide a basis for relevant decisions

 Perform safety signal detection and validation through the medical review of ICSRs and regular review of safety data from all sources

 Prepare/review Risk Management Plan (RMP), provide expertise on the medical content of the safety specification, pharmacovigilance plan and risk minimization activities in the RMP. Ensure risk-minimization strategies are implemented appropriately in relevant documents

 Collaborate with medical and other teams to ensure safety information is effectively communicated to healthcare professionals and patients

 Contribute to safety relevant parts in IND/NDA submission package

Ensure comprehensive compliance

 Monitor regulations, oversee PV processes to promote full compliance, including DSUR/PBRER preparation and submission

 Represent PV team in audits and inspections

 Create and review procedural documents

 Ensure smooth communication channels with the local Marketing Authorization Holders (MAHs) and with the drug regulatory authorities and the drug adverse reaction monitoring authorities

 Develop and deliver training material, provide safety training to company staffs and vendors

 Proactively find solutions to case processing and vendor issues, including safety database acceptance and daily management

 Lead and direct the review license partner safety data exchange agreements for the inclusion of appropriate safety reporting requirements

Recommended Education and Key Competency

 Bachelor’s degree required; medical background and clinical physician experience preferred

 Minimum 10 years of experience in PV, including ICSR management

 Good knowledge of PV regulations for the global pre- and post-market, i.e. China, FDA, EMA, ICH GVP

 Experience with safety databases, e.g. Argus

 Excellent computer skills

 Fluent business English (verbal and written)

 Team player with excellent analytical and proven problem-solving skills

 Excellent communication skills

 Ability to work with deadlines under high pressure

 Works independently