Associate Pharmacovigilance Specialist

1-2 years

Not Disclosed

India

10 March 9, 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

Job Title: Associate Pharmacovigilance Specialist

Location: Karnataka, India

Job Type: Hybrid | Full-Time

Job Overview:

The Associate Pharmacovigilance Specialist is responsible for monitoring biomedical literature for adverse event reporting, indexing, and abstracting. This role requires a strong understanding of scientific terminology, pharmacovigilance regulations, drugs, and therapeutic areas to ensure accurate reporting of safety-relevant information.

Key Responsibilities:

Review and analyze biomedical literature and internal drug safety alerts for individual case safety reports (ICSRs) and other potential safety-relevant information.
Summarize ICSR criteria and safety-related findings in brief narratives.
Apply knowledge of drug labels and safety profiles in assessing biomedical literature.
Ensure accuracy and compliance with regulatory requirements and standard operating procedures.
Track actions and assessments in the drug safety system for audit-ready documentation.
Select relevant articles for inclusion in the client’s product literature database.
Write detailed abstracts and indexes for selected articles, ensuring completeness and precision.
Stay updated on new drugs, therapeutic categories, and biomedical terminology.
Participate in searches, terminology maintenance, and other pharmacovigilance duties as required.

Qualifications & Experience:

Master’s degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
A Dentistry, Physiotherapy, or Nursing degree with hospital-based patient exposure is an advantage.
1-2 years of experience in biomedical literature review for adverse event reporting.
Strong analytical and writing skills to summarize complex biomedical case reports.
Working knowledge of biomedical terminology, drugs, and therapeutic areas.
Experience with commercial and client-specific biomedical literature databases.
Excellent English language skills (reading, writing, speaking, and comprehension).

Preferred Qualifications:

Certification from a professional medical writing association.
Experience in scientific/medical writing.

Work Schedule:

Full-time, permanent role (Monday to Friday, 11:00 AM – 8:00 PM IST).

Why Join Us?

Opportunity to work in a collaborative and supportive environment.
Exposure to multiple therapeutic areas and pharmacovigilance operations.
Personalized training and career development opportunities.

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Associate Pharmacovigilance Specialist

Job Description

Job Overview:

Key Responsibilities:

Qualifications & Experience:

Preferred Qualifications:

Work Schedule:

Why Join Us?

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