Pharmacovigilance QA Executive/ Senior Executive Jobs in Hyderabad

• Opportunity in QA Pharmacovigilance
• Position: Executive/ Senior Executive
• Responsibilities and Role Overview
• How to Apply
• Why Choose Biological E. Limited

Opportunity in QA Pharmacovigilance

Are you a pharmaceutical professional with a keen eye for quality and a background in pharmacovigilance? Look no further! Biological E. Limited is offering an exciting career opportunity for individuals who are passionate about maintaining the highest standards of quality and safety in pharmaceutical products. This is your chance to contribute to a USFDA-approved plant and make a significant impact in the field of pharmacovigilance.

Position: Executive/ Senior Executive

• Location: Pharma SGI – USFDA Approved Plant, Shamirpet, Hyderabad
• Qualification: B.Pharmacy/M.Pharmacy
• Experience: 4 to 9 years

Responsibilities and Role Overview

As an Executive or Senior Executive in QA Pharmacovigilance at Biological E. Limited, you will be responsible for a range of critical tasks to ensure the quality, safety, and compliance of pharmacovigilance activities:

• Pharmacovigilance Monitoring: Monitor pharmacovigilance activities in adherence to SOPs for various regions including the US, EU, and ROW.
• Third Party Coordination: Collaborate with third-party pharmacovigilance services to acquire essential reports such as Medical Information Call Center (MICC) reports, Medical Literature Monitoring (MLM) reports, Individual Case Safety Reports (ICSR), and Draft Periodic Adverse Drug Event Reports (PADER).
• Safety Data Exchange Agreements: Prepare, review, and maintain Safety Data Exchange Agreements (SDEA) to ensure proper documentation and compliance.
• ICSR Review: Conduct a thorough review of Individual Case Safety Reports (ICSR) to ensure accuracy and adherence to protocols.
• Timely Completion of Activities: Ensure that all pharmacovigilance activities are completed and reported within the specified timeframes.
• Calendar Maintenance: Maintain the Medical Literature Monitoring (MLM) schedule and Periodic Adverse Drug Event Reports (PADER) calendar.
• Market Complaints Handling: Take charge of market complaints, conduct investigations, and propose appropriate corrective and preventive actions (CAPA).
• SOP and Procedures: Play a pivotal role in the preparation and review of Standard Operating Procedures (SOP) to maintain consistency and quality.
• Trend Analysis: Prepare market complaint trends as per SOP requirements, contributing to continuous improvement.
• ADE Summary Reports: Prepare Adverse Drug Event (ADE) summary reports as needed, ensuring accurate and comprehensive documentation.
• Change Controls and Deviations: Initiate and manage Change Controls, Deviations, and CAPAs to address potential issues and ensure compliance.

How to Apply

If you are enthusiastic about ensuring the safety and quality of pharmaceutical products through effective pharmacovigilance practices, this opportunity is tailor-made for you. To apply, follow these steps:

• Email: Share your resume with Mahesh.Patsamatla@biologicale.com.

Why Choose Biological E. Limited

At Biological E. Limited, we believe in fostering talent, innovation, and excellence. Joining our team means becoming part of a company dedicated to upholding the highest standards in the pharmaceutical industry. Your contribution in QA Pharmacovigilance will play a crucial role in our commitment to quality, safety, and continuous improvement.