Associate Pharmacovigilance Specialist-8

2+ years

Not Disclosed

Bangalore Noida

10 July 25, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Position: Pharmacovigilance Specialist

Location: Hybrid Work Model, India (Bangalore or Noida)
Hours: Full-time, Monday to Friday

Overview:

We are seeking a skilled Pharmacovigilance Specialist to join our team. This role involves performing critical pharmacovigilance services, including biomedical literature monitoring, adverse event reporting, indexing, and abstracting. Candidates should have a broad knowledge of scientific and medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.

Key Responsibilities:

Literature Analysis: Critically analyze a large volume of biomedical articles and internal drug safety alerts to identify individual case safety reports (ICSRs) and other safety-relevant information that could impact the risk-benefit and/or safety profile of customer products. Ensure compliance with regulatory requirements and standard operating procedures.
Narrative Writing: Write brief and accurate narratives summarizing ICSR criteria and other potentially safety-relevant information from each article.
Safety Assessment: Demonstrate a thorough understanding of client drug labels to effectively perform safety assessments.
Data Tracking: Use drug safety systems to track all actions and assessments, maintaining an audit-ready reference history.
Database Management: Select relevant articles for inclusion in the client's product literature database according to guidelines.
Abstracting and Indexing: Write accurate and detailed abstracts of selected articles, ensuring comprehensive indexing for precise retrieval of literature from the client’s database.
Timely Completion: Ensure the timely completion of indexing and abstracting tasks in accordance with regulatory submission deadlines.
Knowledge Maintenance: Stay informed about new drugs, therapeutic categories, disease entities, and changes in biomedical terminology.

What You Will Need:

Education: Master’s Degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics). A degree in Dentistry, Physiotherapy, or Nursing is an advantage.
Experience: At least 2 years of experience reviewing biomedical literature for adverse event reporting, or an equivalent combination of education and experience.
Skills: Strong writing skills to create succinct, accurate summaries, with working knowledge of biomedical terminology, drugs, and therapeutic areas. Proficiency in database and literature searches is required.
Analytical Ability: Ability to analyze and summarize biomedical case reports, studies, or specific topics accurately.

About the Team:

Our Pharmacovigilance team at Clarivate provides services to global customers across all therapeutic areas. We offer a supportive work environment with personalized training and opportunities to engage in various aspects of pharmacovigilance and customer engagement.

Equal Opportunity Statement:

Clarivate is dedicated to providing equal employment opportunities for all individuals. We comply with all applicable laws and regulations governing non-discrimination in employment.

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Associate Pharmacovigilance Specialist-8

Job Description

Position: Pharmacovigilance Specialist

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