Senior Executive - Pharmacovigilance

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Be the First to Apply Division Piramal Critical Care Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders. PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs. For more details, please visit https://www.piramalcriticalcare.com/global/ Job Title Senior Executive - Pharmacovigilance Job Description The role involves comprehensive pharmacovigilance activities, including end-to-end case management, ICSR tracking and reconciliation, submission to regulatory databases, and continuous literature monitoring. It also includes maintaining safety documentation, preparing compliance data and aggregate reports (PADER/PSUR), and supporting audits, inspections, and regulatory queries. Additionally, the position requires coordination with stakeholders, handling product complaints, managing mailboxes, and ensuring timely compliance reporting to support overall pharmacovigilance system effectiveness. Business: Piramal Critical Care Department: Pharmacovigilance Location: Kurla Travel: No Reporting Structure: (Reports To/ Direct Reports Y/N) - Reports to Senior Manager Essential Qualification: Bachelors/ Masters degree in Pharmacy Relevant Experience: Overall 2-3 years of experience in Pharmacovigilance with at least 1 year of relevant work experience in ICSR processing, Literature screening and authoring of aggregate safety reports like PADERs, PBRERs etc. Roles & Responsibilities: End-to-end case management, including case receipt, facilitation of case follow-up, case download from regulatory authority websites, database entry, peer review and submission to applicable regulatory authorities within stipulated timelines. Mailbox management and tracking of incoming Individual case safety reports (ICSRs). Reconciliation of ICSRs. Enter and/ or submit cases to applicable regulatory authority safety databases. Perform and monitor literature for company molecules. Maintain and update safety logs and safety files. Prepare and share compliance data with QPPV. Provide data for compliance representation/monthly information system. Assist in handling of product complaints and reconciliation. Assist in responding to queries and requests related to safety of products and Pharmacovigilance system from regulatory authorities. Prepare for internal or external audits and inspections. Preparation/Drafting of aggregate reports (PADER and PSURs). Coordination with different stakeholders for data request etc. for fulfilment of Pharmacovigilance responsibilities. Key Competencies: Literature screening and authoring of aggregate safety reports like PADERs, PBRERs. Good communication and interpersonal skills, both written and verbal Ability to manage multiple concurrent tasks Proven ability to meet strict deadlines Ability to work independently and in a team environment Competent in use of desktop applications: Microsoft word, excel and PowerPoint