Varsha Nagotkar

Benefit Risk Officer i @PrimeVigilance

Thane, IN

Participating in signal detection activities including set-up • Review line listings required for preparation of signal detection reports• Drafting complex signal detection reports, including quality control• Evaluating and categorizing potential signals (when signal detection is performed by Benefit-Risk team)• Proposing a course of action whenever a potential signal is identified (when signal detection is performed by Benefit-Risk team)• Record keeping and maintenance of relevant tracking tools• Providing support for preparation of communication with regulatory authorities• Supporting preparation of risk-benefit analyses• Working with other company departments to ensure that signal management is conducted in accordance with relevant PrimeVigilance procedures and regulatory requirements • Ensures readiness for audits and inspections and effective CAPA development• Actively participating to departmental audits and client PV inspections/audits, as applicable• Contributes to ongoing process enhancements, such as developing standard operating procedures and templates• Overseeing quality of signal detection activities• Developing training presentations in the field of expertise and delivering training, as required• Supporting Project Managers and QPPVs, as required• Supporting PV Director, Benefit-Risk Management

Bharati Vidyapeeth

Master of Pharmacy

University of Mumbai

Bachelor's degree