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B.Pharm/M.Pharm QA & Pharmacovigilance Openings | Hyderabad
Biological E. Ltd hiring Executive/Sr. Executive in QA & Pharmacovigilance. 5–9 yrs experience required. Apply now at USFDA-approved plant, Hyderabad.
Biological E. Limited, a trusted leader in pharmaceuticals with global regulatory approvals, is inviting skilled professionals to join its Pharmacovigilance & Quality Assurance team at the USFDA-approved plant in Shamirpet, Hyderabad. This is a remarkable opportunity for candidates with expertise in drug safety, regulatory compliance, and pharmacovigilance operations to contribute to patient safety worldwide.
Company Overview
Founded over 60 years ago, Biological E. Limited (BE) is one of India’s leading pharmaceutical and vaccine manufacturers. With multiple global approvals including USFDA and EMA, BE has played a vital role in strengthening healthcare access globally. The Shamirpet facility in Hyderabad is dedicated to quality-driven manufacturing and compliance with stringent international standards.
Job Role & Responsibilities
As an Executive/Senior Executive – QA & Pharmacovigilance, you will be responsible for:
- Monitoring pharmacovigilance activities in compliance with SOPs, USFDA, EU & ROW guidelines.
- Coordinating with third-party pharmacovigilance service providers to obtain and review Medical Information Call Center (MICC) reports, Medical Literature Monitoring (MLM) reports, Individual Case Safety Reports (ICSRs), and Draft PADERs (Periodic Adverse Drug Event Reports).
- Preparing, reviewing, and maintaining Safety Data Exchange Agreements (SDEAs).
- Ensuring timely reporting and documentation of pharmacovigilance activities.
- Managing market complaints, conducting investigations, and implementing CAPAs (Corrective and Preventive Actions).
- Preparing and reviewing SOPs, ADE (Adverse Event) summary reports, and complaint trend analysis.
- Initiating and managing change controls, deviations, and CAPAs in line with regulatory requirements.
Eligibility / Qualifications
- Education: B.Pharm / M.Pharm
- Experience: 5–9 years of relevant experience in Pharmacovigilance / QA in the pharmaceutical industry.
- Skills Required:
- Strong knowledge of pharmacovigilance regulations (US, EU, ROW).
- Proficiency in SDEA management, ICSR review, and MLM schedules.
- Experience with regulatory compliance and documentation.
- Analytical thinking and problem-solving for handling market complaints and CAPAs.
Location & Salary
- Job Location: USFDA-approved plant, Shamirpet, Hyderabad
- Salary: As per industry standards and candidate experience.
Application Process
Interested and eligible candidates may share their updated CVs with the subject line “Application – QA & Pharmacovigilance (Executive/Sr. Executive)” to:
Mahesh.Patsamatla@biologicale.com
Why Join Biological E.?
- Opportunity to work with an internationally recognized, USFDA-approved facility.
- Gain exposure to global pharmacovigilance practices and audits.
- Be part of a team dedicated to drug safety and patient well-being.
FAQs
Q1. What qualifications are required?
A B.Pharm or M.Pharm degree with 5–9 years of experience in QA or pharmacovigilance is mandatory.
Q2. Is prior pharmacovigilance experience necessary?
Yes, hands-on experience with PV regulations, ICSR, MLM, and PADERs is required.
Q3. Where is the job located?
The role is based at Biological E.’s USFDA-approved plant in Shamirpet, Hyderabad.
Q4. How do I apply?
Send your resume directly to Mahesh.Patsamatla@biologicale.com before the application deadline.
Q5. What skills will strengthen my application?
Regulatory compliance, audit readiness, pharmacovigilance documentation, and CAPA management will be highly valued.
Summary Table
| Company | Biological E. Limited |
|---|---|
| Vacancies | Executive/Sr. Executive – QA & PV |
| Required Education | B.Pharm, M.Pharm |
| Experience | 5–9 Years |
| Location | Shamirpet, Hyderabad |
