Pharmacovigilance Safety Specialist I Vacancy at Precision Medicine

Safety Specialist I Vacancy for Pharmacy & Life Science Graduates | Bengaluru

Apply for Safety Specialist I role at Precision Medicine Group in Bengaluru. Openings for Pharmacy/Life Sciences graduates with 3+ years’ experience.

If you are passionate about pharmacovigilance and want to contribute to advancing patient safety, Precision Medicine Group has an excellent opportunity for you. We are hiring a Safety Specialist I in Bengaluru to strengthen our global safety team. This role is ideal for professionals with a background in pharmacy, nursing, or life sciences, and experience in clinical trial drug safety.

Company Overview

Precision Medicine Group is a leading global organization specializing in clinical research, pharmacovigilance, and advanced therapies. We work with pharmaceutical, biotechnology, and healthcare companies to deliver safe and effective treatments to patients worldwide. With a strong foundation in science and regulatory compliance, our team plays a vital role in improving healthcare outcomes.

Our culture fosters collaboration, innovation, and continuous growth. As part of our safety department, you will work alongside industry experts while gaining exposure to diverse therapeutic areas, including immuno-oncology and advanced therapy medicinal products (ATMPs).

Job Role & Responsibilities

As a Safety Specialist I, you will:

• Process Individual Case Safety Reports (ICSRs) in compliance with SOPs and regulatory guidelines.
• Evaluate safety data for accuracy, completeness, and regulatory reportability.
• Enter case details into the Argus Safety Database.
• Code adverse events, medical history, medications, and tests using MedDRA and WHODrug.
• Draft and review safety case narratives.
• Manage follow-ups and resolve safety queries.
• Generate timely expedited and periodic safety reports.
• Collaborate with data management teams for reconciliation of safety data.
• Support audits, inspections, and regulatory submissions.
• Ensure compliance with ICH, GCP, GVP, and global drug safety regulations.
• Contribute to trial master file documentation and project-specific safety deliverables.

Eligibility / Qualifications

To qualify for this role, you should have:

• Education: Bachelor’s degree in Pharmacy, Nursing, Life Sciences, Biotechnology, Pharmacology, or equivalent. (Preferred: Pharmacy/Nursing graduates).
• Experience: Minimum 3 years in clinical trial drug safety within the Pharma or CRO industry.
• Technical Expertise:
  • Proficiency with Oracle Argus Safety Database.
  • Strong working knowledge of MedDRA, WHODrug, and global safety regulations (FDA, EMA, MHRA).
  • Understanding of ICH-GCP principles.
• Preferred Experience: Early-phase oncology trials, immuno-oncology, and ATMPs.
• Skills:
  • Strong communication and analytical skills.
  • Ability to work collaboratively in cross-functional teams.
  • Detail-oriented with problem-solving abilities.

Location & Work Environment

• Job Location: Bengaluru, India.
• Work Type: Full-time, On-site.
• Industry: Clinical Research, Pharmacovigilance, Pharmaceuticals.

Application Process

Interested candidates can apply directly via the company’s official listing here: Apply Now.

FAQs

Q1. Who can apply for the Safety Specialist I role?
Candidates with a bachelor’s degree in Pharmacy, Nursing, Life Sciences, or related fields, along with 3+ years’ experience in clinical drug safety.

Q2. Is Argus Safety Database experience mandatory?
Yes, proficiency in Argus is required for this role.

Q3. What therapeutic areas will I work on?
You will gain exposure to oncology, immuno-oncology, and advanced therapy medicinal products.

Q4. Is this role open to freshers?
No, a minimum of 3 years’ clinical trial safety experience is required.

Q5. Where is the role based?
This role is based in Bengaluru, India.

Call to Action

Don’t miss this chance to advance your career in pharmacovigilance!
Apply before the position closes to secure your spot with Precision Medicine Group.

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