Pharmacovigilance Executive Opportunity at Jubilant Pharma
Jubilant Pharma Limited, a global pharmaceutical company, is offering an exciting opportunity for a Pharmacovigilance Executive to join their dynamic team. This role involves crucial responsibilities in ensuring regulatory compliance and maintaining high standards of pharmacovigilance.
LOCATION : Greater Noida, Uttar Pradesh
Job Description Overview: In this role, you will be responsible for various pharmacovigilance activities, including case processing, data entry, regulatory compliance, and communication with internal and external stakeholders. Here's a detailed look at the scope of work and key accountabilities:
Scope of Work:
Accountabilities Scope of work:
- Perform literature search and identify the safety information present in the article with regard to Jubilant’s products
- Perform quality check of the ICSR in the safety database to ensure accurate and consistent data entry and processing from adverse event reports/source document following the Company’s Data Entry Conventions.
Principle Accountabilities
- Timely allocation of ICSRs for data entry, quality review, medical review and its distribution in the safety database.
- Preparation of PADERs and other aggregate reports as per the company’s SOP and regulatory guidelines.
- Compilation of data and preparation of RMPs as per the company’s SOP and regulatory guidelines.
- Timely updation of literature tracker as per the exclusion and inclusion criteria of the safety information.
Documentation:
- Updating the QC checklist for the reviewed ICSRs on real time manner.
- Archival of relevant documents and e-mail communications related to RMPs and update the RMP details in the RMP tracker.
- Maintain an awareness of current legislation associated with the Worldwide Regulatory Pharmacovigilance requirements.
- Statutory Compliance:
- Stay updated with current legislation related to worldwide regulatory pharmacovigilance requirements.
- Provide timely and quality information for aggregate reports and signal review, ensuring regulatory compliance.
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Key Responsibilities:
- Conduct case processing and data entry activities within specified timelines.
- Participate in triaging and book-in of various types of reports, including regulatory, EMA MLM ICSR, and literature reports.
- Ensure accurate coding of adverse reactions using PV-MedDRA.
- Maintain documentation of pharmacovigilance SOPs, procedures, and guidelines.
- Communicate effectively with internal and external stakeholders as per requirements.
- Stay informed about current pharmacovigilance regulations and ensure compliance.
How to Apply: If you have a minimum of [mention years of experience required], relevant qualifications in pharmacovigilance, and are looking to advance your career in a globally renowned pharmaceutical company, we encourage you to
apply now.
https://pharmastuff.org.in/job/pharmacovigilance-executive-jubilant-pharma
