Piramal Critical Care (PCC), a key division of Piramal Pharma Limited (PPL), stands as a global leader in hospital generics and the third-largest producer of inhaled anesthetics worldwide. With a strong presence across the USA, Europe, and over 100 countries, PCC is committed to delivering critical care solutions for patients and healthcare providers. Backed by state-of-the-art manufacturing facilities in India and the US, PCC adheres to the highest standards, with approvals from global regulatory bodies such as the US FDA and UK MHRA. Joining Piramal Critical Care means being part of a visionary organization driven by its core values of ethical practices, sustainability, and growth.
Responsibilities in the Job
As an Executive in Pharmacovigilance at Piramal Critical Care, you will take on key responsibilities that ensure the safety and compliance of critical pharmaceutical products. These include:
- Case Management: End-to-end handling of Individual Case Safety Reports (ICSRs), including case receipt, facilitation of follow-ups, database entry, and peer review.
- Mailbox and Database Management: Monitoring incoming ICSRs, reconciling safety reports, and submitting cases to regulatory authority safety databases.
- Literature Screening: Performing and monitoring literature reviews for company molecules.
- Compliance Reporting: Preparing compliance data for internal and external stakeholders, including QPPV (Qualified Person for Pharmacovigilance).
- Product Complaints and Audits: Assisting in the reconciliation of product complaints and preparation for audits and inspections.
- Aggregate Reports: Drafting and preparing Periodic Adverse Drug Event Reports (PADERs) and Periodic Safety Update Reports (PSURs).
- Coordination and Communication: Liaising with internal and external stakeholders for data requests and fulfilling pharmacovigilance responsibilities.
Qualifications
To qualify for this role, candidates must possess:
- Educational Requirements: A Bachelor’s or Master’s degree in Pharmacy (B Pharm/M Pharm).
- Experience:
- 2–3 years of overall experience in pharmacovigilance.
- At least 1 year of hands-on experience in ICSR processing, literature screening, and authoring safety reports such as PADERs and PBRERs.
Key Skills
- Proficiency in ICSR processing, literature screening, and safety reporting.
- Strong communication and interpersonal skills, both written and verbal.
- Ability to manage multiple tasks and meet strict deadlines.
- Team-oriented mindset with the ability to work independently.
- Competence in Microsoft Office applications (Word, Excel, PowerPoint).
