Medical Safety Physician

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