Product Safety Manager

Department: CMRQ (Clinical, Medical, Regulatory and Quality)

Location: Beijing, China

The Position

•    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 6 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;

•    Proficient in both oral and written English.

About the department

In CMRQ, we commit to bringing our products to Chinese market with the fastest speed and top quality, and applying the most scientific way to communicate our products' benefits to our customers. We have 6 team in CMRQ aming to portfolio evaluation and overall strategy; new product approval, licence maintenance, product localization; clinical evidence trial operation Phase (I-IV, NIS); Multiple stakeholders' engagement (HA/KOLs/investigators) and Medical evidence generation/communication.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.