Pharmacovigilance Manager Clini launch Business Solutions

5.0 - 9.0 years

0 Lacs

maharashtra

On-site

As a Pharmacovigilance Specialist, your primary responsibility will be to manage safety reports and information for Aristo products in compliance with regulatory requirements. You will be involved in various aspects of pharmacovigilance activities including aggregate safety reports, individual safety case reports, and drug safety monitoring. In terms of Aggregate Safety Reports, you will need to have a thorough understanding of safety reporting processes and procedures. Your tasks will include authoring and reviewing reports such as PSUR & PBRER for submission to regulatory bodies in various countries. Additionally, you will be expected to develop and validate Risk Management Plans (RMP) for the assigned products, assess risk-benefit profiles, and ensure compliance with regulatory timelines. For Individual Safety Case Reports (ICSRs), you will be responsible for preparing ICSRs based on adverse reactions observed with Aristo products. This will involve appropriate case follow-up, information dissemination, and submission of ICSRs in the required format to regulatory authorities. In Drug Safety Monitoring, you will be managing day-to-day operational activities of the safety system, evaluating safety information, and monitoring the benefit-risk profile of Aristo products throughout their lifecycle. You will also provide support for adverse event and product complaint handling, interact with stakeholders for data collection, and assist in maintaining the Pharmacovigilance System Master File (PSMF). Furthermore, you will contribute to the development and updating of Standard Operating Procedures (SOPs) for the pharmacovigilance system, participate in CAPA processes, and support training activities related to pharmacovigilance. This is a full-time, permanent position that requires a Master's degree and a minimum of 5 years of experience in pharmacovigilance. The work location is in person, and the application deadline is 24/12/2024. Benefits include Provident Fund, and the schedule consists of day and morning shifts. If you are looking to utilize your expertise in pharmacovigilance and contribute to the safety monitoring of pharmaceutical products, this role offers a challenging and rewarding opportunity to make a significant impact.,

Posted 2 weeks ago

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