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Parexel Hiring Drug Safety Specialist – Mohali

Parexel Hiring Drug Safety Specialist
Parexel Hiring Drug Safety Specialist

🔹 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.
Parexel Hiring Drug Safety Specialist
Parexel Hiring Drug Safety Specialist

✔️ 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.
See also  Parexel Hiring Regulatory Affairs Consultant – Remote

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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Parexel Hiring Drug Safety Specialist
Parexel Hiring Drug Safety Specialist
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