Medical Safety Physician at Novartis

Beijing, Beijing, China -

Full Time

Start Date

Immediate

Expiry Date

15 May, 26

Salary

0.0

Posted On

14 Feb, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Safety Science, Reporting, Project Management, Medical Background, Negotiation, Communication, Regulatory Requirements, Signal Detection, Data Evaluation

Industry

Pharmaceutical Manufacturing

Description

Band Level 4 Job Description Summary Act as the deputy of the Local Qualified Person for Pharmacovigilance in Novartis Country Organization to fulfill medical safety oversight and provide safety deliverables for assigned therapeutic areas/ products in China in full drug life-cycles. Job Description Major accountabilities: Act as Qualified Delegate of the Country Patient Safety Head, functionally (in terms of responsibility for PV system) for assigned therapeutic areas/ products. Ensure robust oversight and compliance in terms of reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN, SUSAR, PSUR, DSUR, changes in risk-benefit profile) to Local Health Authorities according to regulatory requirements and Novartis procedures. Provide medical safety support, including safety deliverables in CTA/ (s)NDA/ License Renewal/ Reimbursement dossier is done according to the timeliness described into the respective procedures or as committed with line functions. Play a joint role with global safety leads for safety relevant issues or requests. Represent PS in CTT for Post Approval Commitment (PAC) studies and China bridging clinical trials, with the support by global safety lead if needed. Work in close collaboration with other local and global medical safety functions to ensure accurate evaluation of safety data. Lead local RMP and RMP China addendum creation and approval, based on local regulatory or LHA requirement, if applicable. Conduct local safety signal detection and escalate to global medical safety for potential safety signals identified from all local post-marketing sources per local regulatory requirements. Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract. Responsible for responses to inquiries from LHA on safety issues related, involve in the communication on safety topics related to responsible products with the LHA. Ensure support for and close-out of audits, corrective action plan, investigation, and Health Authority inspections. Essential Requirements: Medical background At least 3 years experience in pharmacovigilance or equivalent field, or at least 2 year safety physician experience. Project management skills Desirable Requirements: Excellent communications and negotiation (networking) skills Quality and results oriented Business mindset Skills Desired Databases, Employee Training, Pharmacovigilance, Reporting, Safety Science, Waterfall Model Improving the lives of people living with disease takes more than innovative science. It takes a focus on the needs of people and a community committed to meeting them. It takes a team of people like you. Working together. Learning together. Thriving together. Discover how you can join us in changing people’s lives. In the context of China Cross-Border Data Transfer (CBDT) policy, if you need to apply for a position in China, please go to the local Recruiting System TaleNov .

Responsibilities

The role involves acting as the deputy of the Local Qualified Person for Pharmacovigilance, ensuring medical safety oversight and delivering safety documentation for assigned therapeutic areas in China across the full drug lifecycle. Key duties include ensuring compliance with reporting/submission of safety information to Local Health Authorities and providing medical safety support for regulatory dossiers.