Group PV Head

Job Description

500+ Ongoing clinical trials;160+ Projects in clinical development;80+ Major submissions planned 2020-
2022. Novartis GDD (Global Drug Development) oversees the development of new medicines
discovered by our researchers and partners. It drives breakthrough innovations to improve and extend
the lives of millions.

Your responsibilities include, but are not limited to:
Your key responsibilities:
Act as Qualified Delegate for Pharmacovigilance in Novartis China Organization for responsible products:
• Work with local Patient Safety and global medical safety to ensure accurate evaluation of safety data. Conduct local safety signal detection and escalate to global safety leads for po-tential safety signals identified from local sources per China health authority and Novartis requirements.
• Lead local core safety documents creation, approval, execution, based on local regulatory requirement, e.g. local Risk Management Plan (RMP), Risk Control Plan (RCP). White or re-view the safety documents/parts in regulatory submissions, including Periodic Safety Update Report (PSUR), Development Safety Update Report (DSUR), National Package Insert (NPI), Benefit-Risk Assessment, safety summary for license renewal, drug intensive monitoring evaluation.
• Represent Novartis Patient Safety to interact with local health authority on safety topics re-lated to responsible products, including responses to inquiries from local health authority. Support the activities with involvement of external experts (e.g. members of trial/program specific data safety monitoring boards, ad-hoc support for Health Authority meetings, etc.). Prepares safety data for Health Authorities review boards/meetings if needed.
• Represent Patient Safety to join clinical project teams/medical affairs to be familiar with the company product’s pipeline and strategy, contribute to the drug development projects and post-marketing programs from local medical safety perspective. Provide scientific expertise during review of study protocol safety sections and Clinical Study Report (CSR), if a Contract Research Organization (CRO) is conducting the trial, or Investigator Initiated Trials (IIT) are conducted, review the contract as needed.
• Contribute local patient safety to maintain the pharmacovigilance system to comply all relat-ed regulations. Ensure support for preparation, conduction and close out of audits, corrective action plan, investigation and Health Authority inspections.
• Other agreed tasks assigned by manager.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the job:
• Health Care Sciences Professional (e.g. Medical Doctor) or equivalent education, training and experience.
• Fluent in both written and spoken English
• Medical background, Safety physician, clinical research physician/medical adviser, or drug safety related experiences are preferred
• Excellent communications and negotiation skills
• Leadership and management skills
• Quality and focus oriented
• Computer skills

Division
Global Drug Development

Business Unit
CMO & PATIENT SAFETY GDD

Location
China

Site
Beijing

Company / Legal Entity
CNIBR Co. Ltd.

Functional Area
Research & Development

Job Type
Full Time

Employment Type
Regular

Shift Work
No