Vaishali Gadade

About Vaishali Gadade

A results-oriented professional with over 8 + years of cumulative experience in Pharmacovigilance & in clinical trials such as data analysis & data insights through the interpretation skills across all phases of the trials, Literature screening and review for safety signals, CAPA & Deviation management (in audits/inspections), Conduct benefit-risk assessments for medicinal products, Oversee and engage in all PV activities within the Pharmacovigilance department.

Experience

1. Project Manager

   Immunoact

   Mar 2024 — Present · IN

   Oversee and engage in all PV activities within the Pharmacovigilance department. Lead, manage, and mentor a team of pharmacovigilance professionals to ensure efficient and effective execution of pharmacovigilance processes.• Work synergistically with Clinical Development, Commercial operations, Medical Affairs, and other departments to ensure the seamless execution of safety-related activities• Oversee pharmacovigilance tasks including ICSR/SAE, SUSAR processing, literature monitoring, signal management, periodic reporting, risk management, and regulatory submissions.• preparation of regulatory documents, such as Periodic Safety Update Reports (PSURs), and Development Safety Update Reports (DSURS).• Lead signal detection activities by analyzing safety data from clinical trials, post-marketing surveillance, and other sources.• Conduct benefit-risk assessments for medicinal products and collaborate with clinical and medical teams to mitigate risks Identify and evaluate emerging safety concerns and work with cross-functional teams to define actions.• Quality and Compliance: Ensure the PV system is fully compliant with global PV and clinical safety legislation and manage PV audits and inspections. • Training and Development - Deliver training on pharmacovigilance processes and standards to staff• Preparation & submission of Risk Management Plans (RMPs), Monitor safety risks and identify opportunities for risk minimization or mitigation strategies.• Serve as the pharmacovigilance representative in meetings with regulatory agencies and other external stakeholders• Develop and oversee the preparation of safety communications, such as Dear Healthcare Professional Letters (DHPLs) or Risk Communication, Communicate safety information to relevant stakeholders internally & externally.• Preparation & review of PV SOPs that are in line with Good Pharmacovigilance Practices (GVP).

Education

• University of Mumbai

  Bachelor's degree, Pharmacy