Pharmacovigilance professionals perform pharmacovigilance services such as biomedical literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs and therapeutic areas, and pharmacovigilance regulations.

Job Overview

Job Summary: Pharmacovigilance professionals perform pharmacovigilance services such as biomedical literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs and therapeutic areas, and pharmacovigilance regulations.

Company Profile: Clarivate provides services to multiple global customers covering all therapeutic areas. It provides a supportive working environment with personalized training, and opportunities to engage in different aspects of pharmacovigilance and customer engagement.

Detailed Job Description

As a Pharmacovigilance Specialist at Clarivate, you will be responsible for:

• Critically analyzing large numbers of articles from biomedical published literature and internal drug safety alerts.
• Identifying individual case safety reports (ICSRs) and other potential safety-relevant information impacting the risk-benefit and/or safety profile of customer’s products.
• Writing brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article.
• Understanding client’s drug labels and using that knowledge effectively when performing safety assessments.
• Completing drug safety reviewing of each biomedical literature batch in a timely, thorough, and accurate manner.
• Using the drug safety system to track all actions and assessments in an audit-ready reference history.
• Selecting articles specific to client’s interest for inclusion in client's product literature database per guidelines.
• Writing accurate, detailed, and complete abstracts of selected articles using good judgment regarding the level of detail required.
• Extracting key points of articles and creating comprehensive and detailed indexes of the abstract contents.
• Ensuring timely completion of indexing and abstracting of articles for assigned drugs in accordance with regulatory submission deadlines.
• Maintaining awareness of new drugs and new therapeutic categories, new disease entities, and changes in biomedical terminology in the published literature.
• Participating in other duties such as searches and terminology maintenance according to business needs.

Minimum Requirements

• Master’s Degree in life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.).
• At least 2 years of experience reviewing biomedical literature for adverse event reporting OR equivalent combination of education and experience.
• Writing skills to support the creation of succinct, accurate, and precise summaries.
• Working knowledge of biomedical terminology, drugs, and therapeutic areas.

About the Team

Pharmacovigilance team at Clarivate provides services to multiple global customers covering all therapeutic areas. It provides a supportive working environment with personalized training, and opportunities to engage in different aspects of pharmacovigilance and customer engagement.

Hours of Work

The team is based out of India (Bangalore or Noida). Hybrid work mode.

How to Apply

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