Pharmacovigilance Executive Opportunity at Jubilant Pharma

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.

2. 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.

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.

Apply now

Tagged as: Good Clinical Practice (GCP)