Novartis Pharmacovigilance jobs – Safety Case SME

Your responsibilities include, but are not limited to:

• Responsible to monitor all case processing-related activities to facilitate oversight on Strategic supplier’s quality and compliance of deliverables
• Support audits/Inspections as Subject Matter Expert, and develop, monitor and implement Corrective and preventative Actions (CAPA) to address safety findings
• Support audit and inspection readiness within the internal and strategic supplier teams supporting case management
• Develop, contribute and maintain guidance documents including providing inputs to PVA and other such safety management plans
• Train and mentor new PS associates and associates from other line functions. Collaborate with Data Management team to enable reconciliation for locking of Clinical database
• Support Patient Safety departments, License partners and medical safety to ensure that reports are accurately collected, evaluated and data based
• Support the testing activities for case processing related safety systems/IT applications. Member of Safety Profiling Teams to ensure that case reports are accurately evaluated and databased, authoring or contributing to Product Specific Guidelines for assigned products
• Support Operational Projects or database validation activities as required. Identify any non-conformity with global procedures, process, and regulatory requirements related to safety case management within Sandoz and strategic suppliers and handle them as per QMS processes

Minimum requirements for Sandoz pharmacovigilance jobs

• Three years of pharmaceutical industry experience, preferably pharmacovigilance. Knowledge of drug safety regulatory requirements and general project management is desirable.
• Good professional verbal and nonverbal communication skills
• Strong negotiation and ability to operate effectively in a global environment and across line functions
• Results driven, self-starter with proactive working style, committed and accountable, transparent working style also under pressure.
• Strong operational and project management skills

Novartis Pharmacovigilance jobs – Safety Case SME APPLY HERE

Novartis Pharmacovigilance jobs – Safety Case SME