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Drug Safety Specialist

4+ years
Not Disclosed
10 Feb. 7, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

📢 Parexel is Hiring – Drug Safety Specialist

📍 Location: Mohali, India
💼 Job ID: R0000030170
📑 Category: Medical Sciences

Job Purpose:

The Drug Safety Specialist will support drug safety management for clinical trials and post-marketing surveillance, ensuring compliance with global regulations and SOPs. Key responsibilities include ICSR processing, literature review, signal detection, regulatory reporting, and medical monitoring support.

Key Responsibilities:

ICSR Processing – Case management, data entry, MedDRA coding, query resolution
Drug Safety Reporting – Regulatory submissions, compliance tracking, report generation
Literature Search & Review – Conducting searches, extracting safety data, updating strategies
Compliance & Quality Control – Ensuring accuracy, meeting regulatory timelines
Mentorship & Training – Supporting new hires, contributing to SOPs & workflows

Required Skills & Experience:

🎓 Education: Degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Biochemistry, Biotechnology, Nursing, etc.)
📌 Experience: Minimum 4 years in Pharmacovigilance/Drug Safety
🛠 Technical Skills: Data analysis, safety databases, literature searches, compliance tracking
🗣 Soft Skills: Strong communication, teamwork, problem-solving, and attention to detail

💡 Advantage: Medical/Dental/Nursing degree with hospital-based experience

🔗 Apply Now!