Job Opportunity: Drug Safety Associate (Pharmacovigilance)

Job Summary

We are currently seeking a dedicated and experienced Drug Safety Associate to join a rapidly growing clinical services organization based in Jubilee Hills, Hyderabad. This role is perfect for a detail-oriented professional with 2–4 years of experience in pharmacovigilance (PV) who is looking to advance their career in drug safety and case processing. The successful candidate will play a critical role in maintaining global safety standards and ensuring regulatory compliance through meticulous case management and surveillance activities.

Key Responsibilities

As a Drug Safety Associate, you will be responsible for the accuracy and integrity of safety data. Your primary duties will include:

• Case Processing: Execute end-to-end Individual Case Safety Report (ICSR) processing in full compliance with global regulatory requirements.
• Safety Surveillance: Conduct comprehensive post-marketing surveillance (PMS) activities to monitor the safety profile of pharmaceutical products.
• Database Management: Utilize the ArisG safety database for efficient case entry, quality review, and workflow management.
• Regulatory Submissions: Manage EudraVigilance reporting requirements and ensure all submissions meet specified timelines.
• Data Quality & Technical Handling: Oversee XML file generation and validation in accordance with E2B R2 and R3 formats.
• Compliance: Ensure all safety data is accurate, consistent, and adheres to strict regulatory guidelines.
• Collaboration: Partner with cross-functional teams within clinical safety operations to support ongoing projects and process improvements.

Requirements

To be considered for this position, candidates must meet the following criteria:

• Education: A degree in B.Pharm, M.Pharm, or a related Life Sciences discipline.
• Experience: 2–4 years of proven experience specifically within the pharmacovigilance sector.
• Technical Proficiency:
  • Hands-on experience with safety databases, with a strong preference for candidates proficient in ArisG.
  • Solid understanding of EudraVigilance systems and XML file handling.
  • Strong knowledge of GVP (Good Pharmacovigilance Practice) guidelines.
  • Expertise in case processing and medical narrative writing.
• Skills: Exceptional analytical abilities and strong written and verbal communication skills.
• Professionalism: Ability to maintain high standards of data integrity in a fast-paced environment.

Work Details

• Location: Jubilee Hills, Hyderabad.
• Interview Process: Please note that the interview process will be conducted via Face-to-Face meetings only (no virtual interviews).
• Joining Timeline: Immediate joiners are highly preferred.

Salary & Benefits

We offer a competitive compensation package and a professional environment that fosters career development.

• Compensation: The salary range for this role is ₹4.5 LPA – ₹7.5 LPA, commensurate with your experience and technical skillset.
• Professional Growth: Gain valuable exposure to diverse clinical services, including Clinical Trial Safety Operations, Regulatory Affairs, and Biostatistics.
• Career Advancement: Opportunities to lead and contribute to high-impact global pharmacovigilance projects within a forward-thinking clinical services organization.

How to Apply

If you meet the eligibility criteria and are eager to take the next step in your pharmacovigilance career, we invite you to submit your application.

Please email your updated CV to: [email protected]

Important: Please ensure your email subject line is formatted as follows:
Subject: Application for Drug Safety Associate – [Your Name]

We look forward to reviewing your application and discussing how your expertise can contribute to our team’s success.