Pharmacovigilance Manager

Role Overview: You will be responsible for ensuring the safety and effectiveness of pharmaceuticals through signal detection, risk management, and regulatory compliance. This includes preparing and reviewing Risk Management Plans (RMPs), aggregate reports, and signal detection reports. Your role will also involve training, authoring SOPs/WIs, and ensuring compliance with Good Pharmacovigilance Practices. Key Responsibilities: - Signal Detection and management - Drafting or reviewing signal detection reports - Preparation and review of Risk Management Plans (RMP) - Preparation and review of Risk Management Plan aggregate reports (PADERs/PSURs) - Handling additional Risk Minimization Measures (aRMM) activities - Preparing signal and aggregate report schedules - Ensuring all Pharmacovigilance activities are conducted in accordance with SOPs, Work Instructions, Good Pharmacovigilance Practices, Good Clinical Practice guidelines, and regulatory requirements - Providing training on signal and aggregate activities to team members, CPL employees, and new employees - Authoring and reviewing SOPs and WIs as required - Preparation of line listing for signal and aggregate reports Qualifications Required: - Bachelor's degree in Pharmacy, Life Sciences, or related field - Previous experience in pharmacovigilance or drug safety - Knowledge of regulatory requirements and Good Pharmacovigilance Practices Please Note: Any other actions and responsibilities will be agreed upon with Management. For further details, kindly share your resumes on mahek.chandnani@cadilapharma.com.,