Clarivate | Pharmacovigilance Specialist | Job Opportunity

Pharmacovigilance Specialist Job Opportunity at Clarivate

Are you a skilled Pharmacovigilance Specialist looking for a rewarding opportunity? Join our team at Clarivate, a global leader in providing insights and analytics to accelerate the pace of innovation. We are currently seeking a talented individual to join our Pharmacovigilance (PV) team in Bengaluru (Bangalore) Urban, KA.

Position: Pharmacovigilance Specialist

Reports To: Director, Consulting; Senior Manager, Pharmacovigilance; Manager, Pharmacovigilance

Organization: Clarivate Analytics

Job Summary:

As a Pharmacovigilance Specialist, you will play a vital role in our PV Literature Screening team. Your responsibilities will include performing literature monitoring, assessing adverse events reporting, indexing, and abstracting using your broad knowledge of scientific terms, medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.

What you will need:

• A degree in Dentistry/physiotherapy/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.
• At least 2-4 years of experience reviewing biomedical literature for adverse event reporting.
  • OR equivalent combination of education and experience (i.e., an information science degree with at least 2 years of relevant working knowledge of supporting drug and patient safety)
• Related experience in drug safety/ pharmacovigilance is desirable.
• Strong analytic ability to analyse and summarize the main points of biomedical case reports, studies, or specific topics.
• At least 2 years of experience using writing skills to support the creation of succinct, accurate, and precise summaries.
• At least 2 years of working knowledge of biomedical terminology, drugs, and therapeutic areas

What will you be doing in this role?

• Critically analyses large numbers of articles from biomedical published literature and internal drug safety alerts and identifies individual case safety reports (ICSRs) as well as other potential safety relevant information impacting the risk-benefit and/or safety profile of customer’s products, as per applicable regulatory requirements and standard operating procedures.
• Writes brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article.
• Demonstrates understanding of client’s drug labels and uses that knowledge effectively when performing the safety assessments.
• Completes drug safety reviewing of each biomedical literature batch in a timely, thorough, and accurate manner in accordance with client’s standards of timeliness and quality.
• Uses drug safety system to track all actions and assessments in an audit-ready reference history.
• Selects articles specific to client’s interest for inclusion in client’s product literature database per guidelines.
• Writes accurate, detailed, and complete abstracts of selected articles using good judgement regarding the level of detail required and excellent organization, grammar, and syntax.
• Extracts key points of articles and creates comprehensive and detailed indexes of the abstract contents to ensure precise and complete retrieval of literature from client’s database.
• Ensures timely completion of indexing and abstracting of articles for assigned drugs in accordance with regulatory submission deadlines.
• Maintains an awareness of new drugs and new therapeutic categories, new disease entities, and changes in biomedical terminology in the published literature.
• Participates in other duties such as searches and terminology maintenance according to business needs and per the training provided.

About 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, Noida and Hyderabad) and works from 11:00 AM IST to 8:00 PM IST Monday-Friday. Hybrid work mode – need to work from office at least 2 to 3 days a week, subject to change as per business needs

Apply online