Support the PV operational processes and local PV compliance management, ensuring compliance with NN procedures and regulatory requirements:
Act as a key partner who provides input, during the process of establishing local programs, comments on proposals for vigilance language, content, and establishment of necessary controls on collection and reporting of safety information.
Oversee safety in post-marketing programs, including but not limited to program assessment, training, PV qualification assessment of external partners, compliance check on external partners and project owners, PV agreements/SDEA review, coordination with Global Patient Safety etc.
Develop and maintain local procedures to ensure compliance with NN procedures and regulatory requirements.
Support PV audit/inspection readiness and prepare PV audits and HA inspections.
Provide PV guidance to internal and external stakeholders.
Qualifications
Master's degree or above of clinical medicine, pharmacy or relevant;
Min 8 years experience in pharmaceutical industry or related industry like medical devices or healthcare industry;
Min 5 years in pharmacovigilance function;
Familiar with China, EU, ICH pharmacovigilance legislation;
