Job Description

We are looking for Lead 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 customers productsAbout You - experience, education, skills, and accomplishments

• Masters 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.
• Around 7 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 6 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.
• At least 6 years of experience using writing skills to support the creation of succinct, accurate, and precise summaries.
• At least 6 years of working knowledge of biomedical terminology, drugs, and therapeutic areas
• Proficient in database/literature searches
• Excellent interpersonal, verbal / written communication skills
• Ability to evaluate data and draw conclusions independently.
• Ability to manage multiple and varied tasks and prioritize workload with attention to detail.
• Ability to train and mentor people.

It would be great if you also had the following:

• Certification from a professional medical writers 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 customers products, as per applicable regulatory requirements and standard operating procedures.
• Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article.
• Demonstrates understanding of clients drug labels and uses that knowledge effectively when performing safety assessments.
• Completes drug safety reviewing of each biomedical literature batch in a timely, thorough, and accurate manner in accordance with the clients standards of timeliness and quality.
• Uses a drug safety system to track all actions and assessments in an audit-ready reference history.
• Select articles specific to the clients interest for inclusion in the client's 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 clients 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.
• Works closely with the reporting Manager in client engagement activities.
• Actively involved in internal/client audits and inspections.

About the TeamThe 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 WorkHybrid work mode. Mon-Friday (11:00 AM IST to 8:00 PM IST)At Clarivate, we are committed to providing equal employment opportunities for all persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.

Clarivate