Pharmacovigilance Specialist - Publication indexing/abstracting

We are looking for Pharmacovigilance Specialist to join our Pharmacovigilance (PV) team (offices working in Hybrid model). This is an amazing opportunity to support the team to perform literature monitoring and assessing for adverse events reporting, indexing, and abstracting by using broad knowledge of scientific terms and medical terminology, drugs, therapeutic areas, and pharmacovigilance regulations.

Joining our team of PV Literature Screening, you will support the team for analysis of Literature citations for 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.

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/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 analyze and summarize the main points of biomedical case reports, studies, or specific topics
• Possesses experience in the Indexing of abstracts from literature. Works closely with the manager to provide constructive feedback to primary screeners who fail to report AEs.
• At least 2 year of experience using writing skills to support the creation of succinct, accurate, and precise summaries
• At least 2 year of working knowledge of biomedical terminology, drugs, and therapeutic areas

It would be great if you also had the following:

• Certification from a professional medical writer s association
• Experience with commercial and client-specific biomedical literature databases
• Scientific/medical writing background

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 the client s timeliness standards and quality.
• Uses a drug safety system to track all actions and assessments in an audit-ready reference history.
• Selects articles specific to the client s interest for inclusion in the clients product literature database per guidelines.
• Writes accurate, detailed, and complete abstracts of selected articles using good judgment 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 the 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.

About the Team

The PV Literature team supports multiple customers covering all therapeutic areas. It is a supportive working environment with personalized training, and opportunities to engage in different aspects of pharmacovigilance and participate in customer upgrade planning if desired.

Hours of Work

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

11 am -8 PM IST