Senior Pharmacovigilance Specialist

5-7 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 excellent opportunity to support literature monitoring and adverse event reporting by applying a comprehensive understanding of scientific terms, medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations. The position operates in a hybrid work model.

About the Role

As a member of our PV Literature Screening team, you will be responsible for analyzing literature citations related to individual case safety reports (ICSRs) and other safety-relevant information that impacts the risk-benefit and safety profile of our clients' products.

Key Responsibilities

Critically review and analyze biomedical literature and internal drug safety alerts to identify ICSRs and other safety-relevant information.
Summarize findings and write brief narratives of ICSR criteria and potentially relevant safety information.
Demonstrate a thorough understanding of client drug labels and apply this knowledge in safety assessments.
Complete drug safety reviews of literature batches accurately and timely, adhering to client standards and regulatory requirements.
Use drug safety systems to maintain an audit-ready history of all actions and assessments.
Select articles for inclusion in the client's product literature database based on client-specific guidelines.
Write detailed and accurate abstracts of selected articles, ensuring high standards of organization, grammar, and syntax.
Extract and index key points from articles to ensure precise retrieval from the client's database.
Stay informed about new drugs, therapeutic categories, disease entities, and updates in biomedical terminology.

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 hospital-based patient exposure are also advantageous.
Minimum of 7 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).
At least 5 years of experience in writing concise and accurate summaries and a strong background in 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 environment and maintain a client-focused approach.
Strong analytic skills to evaluate data and draw independent conclusions.
Experience managing 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.

About the Team

The PV Literature team supports a wide range of therapeutic areas and provides a supportive work environment with personalized training. Team members have opportunities to engage in various aspects of pharmacovigilance and participate in customer upgrade planning if desired.

Work Schedule

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

Equal Opportunity

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

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Senior Pharmacovigilance Specialist

Job Description

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