Parexel Hiring Drug Safety Specialist – Mohali
🔹 Salary: ₹5 – 9 LPA
🔹 Location: Mohali
🔹 Education: B.Pharm, M.Pharm, Pharm.D, MSc, BSc, MBBS, BDS, Nursing, Physiotherapy
🔹 Work Mode: Onsite
Job Role: Drug Safety Specialist
As a Drug Safety Specialist, you will be responsible for ensuring pharmacovigilance compliance, managing drug safety reports, and assisting in regulatory submissions. Parexel Hiring Drug Safety Specialist
Key Responsibilities
1️⃣ General Duties
- Maintain expertise in drug safety regulations, SOPs, and labeling guidelines.
- Ensure compliance with global pharmacovigilance reporting obligations.
- Support regulatory audits and inspections.
- Work closely with clients and internal stakeholders to ensure high-quality pharmacovigilance deliverables.
- Mentor new team members when required.
2️⃣ Case Processing
- Monitor and triage Individual Case Safety Reports (ICSRs) from various sources.
- Conduct medical coherence and data consistency checks.
- Enter and process safety data into the pharmacovigilance database.
- Perform MedDRA coding, causality assessment, and seriousness evaluation.
- Prepare and submit safety reports to regulatory authorities and partners.
3️⃣ Regulatory & Literature Review
- Conduct literature searches, signal detection, and safety monitoring.
- Maintain local and international pharmacovigilance literature sources.
- Support expedited regulatory reporting and electronic safety submissions.
- Track and manage regulatory submission cases as per SOPs.
Required Qualifications & Skills
✔️ Education:
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Nursing, MBBS, BDS, Physiotherapy, Microbiology, Biochemistry, or Biotechnology.
✔️ Experience:
- 2+ years in pharmacovigilance or drug safety.
- Expertise in ICSR processing and literature screening.
- Hands-on experience with global and local safety regulations.
✔️ Skills:
- Strong understanding of pharmacovigilance and drug development processes.
- Expertise in MedDRA, WHO Drug Dictionary, and literature search tools.
- Regulatory submission experience.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint).
- Strong problem-solving, analytical, and communication skills.
Why Join Parexel?
✅ Work-Life Balance & Growth Opportunities
✅ Challenging & Impactful Projects
✅ Competitive Salary (₹5 – 9 LPA)
✅ Insurance & Employee Benefits
✅ Be Part of a Global Leader in Drug Safety & Regulatory Compliance
How to Apply?
This is a verified job with an online application process. If you meet the qualifications, apply now to advance your career in pharmacovigilance! Parexel Hiring Drug Safety Specialist
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