Department: MRQ (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
Masters 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;
Proficient in both oral and written English.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.
Required Experience:
Manager
You will be part of the Gulf Cluster sales team based in Qatar. You will report to the Country Sales Manager. The local team consists of approx 10 employees, and has highly-engaged and experienced members that are looking for a new teammember.