Clarivate Senior Pharmacovigilance Specialist Role For Life Sciences, Apply Now
Senior Pharmacovigilance Specialist
Location: Noida, Uttar Pradesh, India
Industry: Life Sciences & Healthcare
Type: Hybrid
Job ID: JREQ125695
Posted Date: June 11th, 2024
Job Summary:
The Senior pharmacovigilance specialist performs 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. Person 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.
What would you do in this role?
- Critically analyze large numbers of articles from biomedical published literature and internal drug safety alerts and identify 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.
- Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article.
- Demonstrate understanding of client’s drugs labels and use that knowledge effectively when performing the safety assessments.
- Complete 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.
- Use drug safety system to track all actions and assessments in an audit-ready reference history.
- Select articles specific to client’s interest for inclusion in the client’s product literature database per guidelines.
- Write accurate, detailed, and complete abstracts of selected articles using good judgment regarding the level of detail required and excellent organization, grammar, and syntax.
- Extract key points of articles and create comprehensive and detailed indexes of the abstract contents to ensure precise and complete retrieval of literature from the client’s database.
- Ensure timely completion of indexing and abstracting of articles for assigned drugs in accordance with regulatory submission deadlines.
- Maintain awareness of new drugs and new therapeutic categories, new disease entities, and changes in biomedical terminology in the published literature.
- Participate in other duties such as searches and terminology maintenance according to business needs and per the training provided.
About You (Education/Skills/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 a hospital-based environment, would be an advantage.
- At least 5-6 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 5 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 5 years of experience using writing skills to support the creation of succinct, accurate, and precise summaries.
- At least 5 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.
It would be good 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
Work hrs: Monday to Friday 11 am to 8 PM IST
Apply for the position at the following link: Apply Now
Keywords: Senior Pharmacovigilance Specialist, Life Sciences, Healthcare, Pharmacovigilance Regulations, Biomedical Literature, Adverse Event Reporting. Clarivate Senior Pharmacovigilance Specialist Role For Life Sciences, Apply Now. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook
