Senior Pharmacovigilance Specialist

6+ years

Not Disclosed

Noida

10 Aug. 7, 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, 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 Summary

We are seeking a Senior Pharmacovigilance Specialist to join our Pharmacovigilance (PV) team. This role offers an exciting opportunity to contribute to literature monitoring, adverse event reporting, indexing, and abstracting. You will leverage your extensive knowledge of scientific terms, medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations in a hybrid work environment.

Role Overview

As part of our PV Literature Screening team, you will analyze literature citations for individual case safety reports (ICSRs) and other safety-relevant information, assessing their impact on the risk-benefit and safety profile of our clients' products.

Qualifications

Master’s Degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics). Degrees in Dentistry, Physiotherapy, or Nursing with patient exposure in a hospital environment are also advantageous.
Minimum of 6 years of experience in reviewing biomedical literature for adverse event reporting, or an equivalent combination of education and experience (e.g., an information science degree with at least 5 years of relevant experience in drug and patient safety).
Related experience in drug safety or pharmacovigilance is desirable.
Strong analytical skills to review and summarize biomedical case reports, studies, or specific topics.
At least 6 years of experience in creating succinct, accurate, and precise summaries.
Extensive knowledge of biomedical terminology, drugs, and therapeutic areas.
Proficiency in database and literature searches.
Excellent interpersonal, verbal, and written communication skills.
Ability to work collaboratively in a team and maintain a client-focused approach.
Strong capability to evaluate data independently and manage multiple tasks with attention to detail.

Preferred Qualifications

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

Responsibilities

Analyze large volumes of biomedical literature and internal drug safety alerts to identify ICSRs and other safety-relevant information, following regulatory requirements and standard operating procedures.
Write brief narratives summarizing ICSR criteria and other safety-relevant details in each article.
Utilize understanding of client drug labels effectively during safety assessments.
Review biomedical literature batches in a timely and accurate manner, adhering to client standards and quality expectations.
Maintain an audit-ready history of all actions and assessments using a drug safety system.
Select and include articles in the client's product literature database based on guidelines.
Write detailed and accurate abstracts of selected articles with excellent organization, grammar, and syntax.
Extract key points and create comprehensive indexes of abstract contents for precise retrieval from the client’s database.
Ensure timely completion of indexing and abstracting tasks in line with regulatory submission deadlines.
Stay informed about new drugs, therapeutic categories, disease entities, and updates in biomedical terminology.

About the Team

The PV Literature team serves multiple customers across various therapeutic areas. We offer a supportive work environment with personalized training and opportunities to engage in diverse aspects of pharmacovigilance. Team members may also participate in customer upgrade planning.

Work Schedule

This is a full-time, permanent position with a work schedule of Monday to Friday.

Equal Opportunity

At Clarivate, we are committed to providing equal employment opportunities for all individuals. We adhere to all applicable laws and regulations governing non-discrimination in employment practices.

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Senior Pharmacovigilance Specialist

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