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Drug Safety Specialist

4+ years
Not Disclosed
10 Feb. 4, 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

Drug Safety Specialist

Location: Mohali, India
Job ID: R0000030170
Category: Medical Sciences

About the Role:

The Drug Safety Specialist is responsible for supporting drug safety management activities in clinical trials and post-marketing, ensuring compliance with relevant regulations and SOPs. This role involves the processing of Individual Case Safety Reports (ICSRs), literature searches, signal detection, regulatory submissions, and reporting.

Key Responsibilities:

  • Case Processing & Data Management:

    • Monitor and process incoming safety reports from various sources (e.g., mailboxes, literature, Eudravigilance).
    • Triage reports for completeness, medical accuracy, and compliance with client guidelines.
    • Perform data entry into safety databases and MedDRA coding.
    • Ensure proper causality assessments, expectedness, and seriousness criteria for events.
    • Create medically cohesive case narratives and prepare safety reports.
  • Drug Safety Reporting & Compliance:

    • Ensure timely and accurate submission of safety reports to regulatory authorities, investigators, and business partners.
    • Maintain local drug safety reporting requirements and handle expedited reporting procedures.
    • Perform quality control checks on safety reports, line listings, and tabulations.
  • Literature Search & Review:

    • Formulate and maintain search strategies for identifying relevant scientific literature.
    • Perform data entry of valid cases into the safety database and maintain local journals for literature searches.
    • Review search strategies and update them based on new requirements or database thesauri changes.
  • Training & Mentoring:

    • Participate in and conduct internal training sessions on drug safety and project-specific topics.
    • Assist with mentoring new recruits and provide guidance on drug safety procedures.

Skills and Competencies:

  • Knowledge of drug safety, pharmacovigilance, and global safety regulations.
  • Strong analytical and problem-solving skills with the ability to evaluate safety data.
  • Excellent verbal and written communication skills.
  • Proficiency in database searches, Microsoft Office, and web-based applications.
  • Ability to work collaboratively in a team environment and manage multiple tasks with attention to detail.

Qualifications:

  • Experience: At least 4 years in drug safety or pharmacovigilance.
  • Education: A degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.), or relevant experience in Pharmacovigilance.
  • Desirable: Degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing.

Additional Information:

This role involves collaborating with clients, maintaining regulatory compliance, and ensuring the highest quality in drug safety management.