Senior Pharmacovigilance Specialist

5+ 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: Senior Pharmacovigilance Specialist

Location: Hybrid Work Model
Hours: Full-time, Monday to Friday

Overview:

We are seeking a Senior Pharmacovigilance Specialist to join our Pharmacovigilance (PV) team. This role offers a unique opportunity to contribute to literature monitoring, adverse event reporting, and indexing by leveraging extensive knowledge of scientific and medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.

Key Responsibilities:

Literature Analysis: Critically analyze a high 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 our customers' products.
Narrative Writing: Write concise and accurate narratives summarizing ICSR criteria and other relevant safety information from each article.
Safety Assessment: Demonstrate a thorough understanding of client drug labels to effectively perform safety assessments.
Timely Reviews: Complete drug safety reviews for biomedical literature batches promptly and accurately, adhering to client standards and quality requirements.
Data Tracking: Use a drug safety system to track all actions and assessments, maintaining an audit-ready reference history.
Database Management: Select articles relevant to the client's interests for inclusion in the product literature database according to guidelines.
Abstracting and Indexing: Write detailed and complete abstracts of selected articles, ensuring precise and comprehensive indexing for accurate literature retrieval.
Knowledge Maintenance: Stay updated on new drugs, therapeutic categories, disease entities, and changes in biomedical terminology.

About You:

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 a plus.
Experience: At least 5-6 years of experience reviewing biomedical literature for adverse event reporting, or an equivalent combination of education and experience. Experience in drug safety/pharmacovigilance is desirable.
Skills: Strong analytical ability, excellent writing skills for creating precise summaries, and in-depth knowledge of biomedical terminology and therapeutic areas. Proficiency in database and literature searches is required.
Communication: Excellent interpersonal, verbal, and written communication skills, with a client-focused approach to work. Ability to work collaboratively in a team environment and independently draw conclusions from data.
Organization: Ability to manage multiple tasks, prioritize workloads, and pay attention to detail.

Desirable Skills:

Certification from a professional medical writer’s association.
Experience with commercial and client-specific biomedical literature databases.
Background in scientific or medical writing.

About the Team:

Our PV Literature team supports a diverse range of customers across all therapeutic areas. We provide a supportive work environment with personalized training and opportunities for engagement in various aspects of pharmacovigilance, including participation in customer upgrade planning.

Equal Opportunity Statement:

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

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Senior Pharmacovigilance Specialist

Job Description

Position: Senior Pharmacovigilance Specialist

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