We are seeking an exceptional leader to head our Pharmacovigilance function for North America. Incumbent will also provide oversight on medical affairs and medical information services and support in providing strategic inputs to cross functional teams as well as initiate, improve and monitor the execution of existing systems.
The role will be based in Princeton, NJ and report to Global Head of Pharmacovigilance
Roles & Responsibilities:
- Maintain and identify pharmacovigilance processes and procedures to be documented and set up. Ensure that the pharmacovigilance Quality Management System and achieve compliance with US regulatory requirements
- Continuously monitoring NAG pharmacovigilance regulations and notifying Global Pharmacovigilance (GPV) of any changes
- Overseeing compliance with NAG pharmacovigilance regulations (e.g. with respect to the intake of adverse events, processing, timeliness of submission and quality of expedited Individual Case Safety Reports (ICSRs), PADERs, and timely responses to Regulatory Authority requests)
- Lead the interaction between the USFDA and Health Canada for all aspects of pharmacovigilance and product safety
- Ensuring that GPV is notified of changes to the product portfolio, including new approvals, and sharing the Prescribing Information (PI), both new and revised
- Ensuring that GPV is promptly notified of any significant regional safety concerns
- Having awareness of any post-authorization safety studies requested by the Regulatory Authority for the region
- Anchor drug safety regulatory inspection in US (FDA regulatory agencies), participate in audits and provide support in external audits. Responsible for driving successful PV audits to achieve no critical findings and provide post inspection report with corrective action plan
- Review current reporting period against historical data to conduct detail evaluation of risks / identify potential risk areas. Review existing products for safety risks and generate report on product risk-benefit ratio and develop proposal for regulatory agencies and manage the REMS program, budget and ensure regulatory sign off and take corrective actions when necessary
- Support in the development and execution of North America Medical Affairs plans and Dr. Reddy's Canada Medical Affairs plans in consideration of best clinical practices and overall corporate objectives aligned with commercial Brand strategy
- Provide oversight of the medical information services for North America and ensure seamless communication with Pharmacovigilance service providers
- Engage effectively cross-functionally, maximizing functional reporting relationships, and ensure successful implementation of company strategies. Support scientific congress attendance via pre-meeting planning and post-meeting CI reporting
- Ensuring oversight of any local pharmacovigilance service providers; if applicable
- Providing support for regional audits and inspections, as required
- Overseeing the training of non-PV personnel and PV personnel in the region
- Drive communication and collaboration on PV related matters with the individual countries of the region through regular leadership meetings, ensuring open and clear communication on PV issues have the appropriate access and input to the global PV system, and the ability to escalate regional/local safety issues
- Oversee pharmacovigilance trainings, QMS and compliance activities for presentation at monthly compliance meeting and inclusion in monthly report as necessary. Develop and implement appropriate regional and local PV procedural documents, training modules in alignment with global documents and processes
- Any other pharmacovigilance activity as delegated by the Global Head of Pharmacovigilance
Incumbent should be willing to work in person from our Princeton, NJ office