Senior Pharmacovigilance Specialist

5-6 years

Not Disclosed

Noida

10 Aug. 13, 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, working in a hybrid model. This is an excellent opportunity to contribute to the team by performing literature monitoring and assessing adverse event reports, indexing, and abstracting, leveraging your comprehensive knowledge of scientific and medical terminology, pharmaceuticals, therapeutic areas, and pharmacovigilance regulations.

In this role, you will support our PV Literature Screening team by analyzing literature citations for individual case safety reports (ICSRs) and identifying other safety-relevant information that could impact the risk-benefit or safety profile of our customers' products.

About You – Experience, Education, Skills, and Accomplishments

Master’s Degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
A degree in Dentistry, Physiotherapy, or Nursing, involving patient exposure in a hospital environment, is advantageous.
At least 6 years of experience in reviewing biomedical literature for adverse event reporting or a combination of relevant education and experience (e.g., an information science degree with at least 5 years of relevant experience in drug and patient safety).
Experience in drug safety/pharmacovigilance is desirable.
Strong analytical skills for summarizing key points of biomedical case reports, studies, or topics.
Minimum of 6 years of experience in scientific writing, including creating accurate and precise summaries.
Proficiency in biomedical terminology, pharmaceuticals, and therapeutic areas, with at least 6 years of relevant experience.
Expertise in database and literature searches.
Excellent interpersonal and verbal/written communication skills.
Ability to work collaboratively and effectively in a team-oriented environment.
Client-focused approach to work with a strong ability to evaluate data and draw independent conclusions.
Ability to manage multiple tasks, prioritize workload, and maintain attention to detail.

Preferred Qualifications

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

Key Responsibilities

Critically analyze a large volume of articles from biomedical literature and internal drug safety alerts, identifying individual case safety reports (ICSRs) and other safety-relevant information that could affect the risk-benefit or safety profile of customer products, in line with regulatory requirements and standard operating procedures.
Write concise narratives summarizing the ICSR criteria and any other potential safety-relevant information in each article.
Apply a thorough understanding of the client's drug labels during safety assessments.
Review biomedical literature batches for drug safety in a timely and accurate manner, meeting client deadlines and quality standards.
Use a drug safety system to document actions and assessments, ensuring an audit-ready reference history.
Select articles pertinent to the client's interests for inclusion in their product literature database, following specific guidelines.
Write detailed abstracts of selected articles, ensuring accuracy, organization, and correct grammar.
Extract key points from articles and create comprehensive indexes to facilitate precise and complete retrieval of literature from the client's database.
Ensure timely completion of indexing and abstracting of articles for assigned drugs in accordance with regulatory submission deadlines.
Stay updated on new drugs, therapeutic categories, diseases, and changes in biomedical terminology in published literature.

About the Team

The PV Literature team supports multiple customers across all therapeutic areas, providing a collaborative work environment with personalized training and opportunities to engage in various aspects of pharmacovigilance. There are also opportunities to participate in customer upgrade planning if desired.

Hours of Work

This is a full-time, permanent position, working weekdays from Monday to Friday.

At Clarivate, we are committed to providing equal employment opportunities for all individuals, ensuring compliance with all applicable laws and regulations related to non-discrimination in every location we operate.

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Senior Pharmacovigilance Specialist

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