Summary
About the Role
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
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
