Vigilare Biopharma Pvt. Ltd. is hiring an ICSR – Drug Safety Associate in Hyderabad for experienced Pharmacovigilance professionals with 3+ years of experience.

Job Details

• Company: Vigilare Biopharma Pvt. Ltd.
• Position: ICSR – Drug Safety Associate
• Department: Pharmacovigilance / Drug Safety
• Experience: 3+ Years
• Qualification: B.Pharm, M.Pharm, Pharm.D, M.Sc (Life Sciences), or related field
• Location: Kukatpally, Hyderabad
• Work Mode: Onsite
• Shift: Day Shift
• Joining: Immediate joiners preferred

Vigilare Biopharma Hiring ICSR – Drug Safety Associate

Are you an experienced Pharmacovigilance professional looking for an ICSR Drug Safety Associate job in Hyderabad? Vigilare Biopharma Pvt. Ltd. is inviting applications from qualified candidates with experience in Individual Case Safety Report (ICSR) processing and Drug Safety operations.

This opportunity is suitable for candidates with a strong understanding of Pharmacovigilance, ICSR case processing, safety data review, quality checks, MedDRA coding, WHODrug, and regulatory compliance.

The selected candidate will join the Pharmacovigilance team and support safety case processing activities while ensuring accuracy, quality, and compliance with applicable SOPs and regulatory requirements.

Key Responsibilities

As an ICSR – Drug Safety Associate, you will be responsible for:

• Processing Individual Case Safety Reports (ICSRs) received from various sources.
• Performing safety data entry and case processing activities.
• Reviewing cases for completeness, accuracy, and quality.
• Conducting quality checks according to established procedures.
• Ensuring compliance with internal SOPs and applicable regulatory guidelines.
• Supporting safety database activities and other Pharmacovigilance processes.
• Maintaining accurate documentation and case records.
• Meeting defined timelines and productivity expectations.
• Working closely with cross-functional teams.
• Supporting continuous quality and compliance within Drug Safety operations.

Qualifications and Requirements

Candidates applying for this Drug Safety Associate job should meet the following requirements:

• 3+ years of experience in Pharmacovigilance or Drug Safety.
• Practical experience in ICSR case processing.
• Educational qualification in:
  • B.Pharm
  • M.Pharm
  • Pharm.D
  • M.Sc in Life Sciences
  • Or another related field
• Good understanding of Pharmacovigilance and Drug Safety concepts.
• Knowledge of the ICSR workflow and safety case processing.
• Familiarity with MedDRA and WHODrug is an advantage.
• Knowledge of ICH-GCP guidelines is preferred.
• Strong attention to detail and analytical skills.
• Good communication and documentation skills.
• Ability to collaborate effectively in a team environment.

Why Consider This Pharmacovigilance Opportunity?

This role offers an opportunity to contribute to core Drug Safety and Pharmacovigilance operations in an onsite working environment. Candidates with hands-on experience in ICSR processing can further develop their expertise in safety case management, regulatory compliance, quality review, and Pharmacovigilance processes.

The position may be particularly suitable for professionals seeking an ICSR job in Hyderabad, Drug Safety Associate jobs, or experienced Pharmacovigilance jobs in Hyderabad.

Salary and Benefits

The compensation package is expected to be competitive and based on the candidate’s experience, skills, and interview performance.

Estimated salary range: ₹4,50,000 – ₹8,00,000 per year.

Benefits and employment terms may be discussed during the recruitment process.

How to Apply?

Interested and eligible candidates can share their updated CV with the recruitment team.

Email: hr@vigilarebp.com

WhatsApp / Queries: 8317622718