Clarivate Pharmacovigilance Remote Job Opening – Pharma Apply Online
Senior Pharmacovigilance Specialist
Karnataka, India
Noida, Uttar Pradesh, India
Sciences & Healthcare
Remote
Job ID: JREQ128534
Posted Date: July 23rd, 2024
We are looking for a Senior Pharmacovigilance Specialist to join our Pharmacovigilance (PV) team (offices working in a Hybrid model). This is an amazing opportunity to support the team in performing 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 in the 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 a hospital-based environment, would be an advantage
- At least 5 – 6 years of experience reviewing biomedical literature for adverse event reporting OR an 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 work collaboratively and effectively in a team environment
- Client-focused approach to work
- Ability to evaluate data and draw conclusions independently
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
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 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 drug labels and use that knowledge effectively when performing safety assessments
- Complete 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
- Use a drug safety system to track all actions and assessments in an audit-ready reference history
- Select articles specific to the 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
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)
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.
Keywords: Senior Pharmacovigilance Specialist, Pharmacovigilance, Drug Safety, Biomedical Literature, Healthcare, Life Sciences. Clarivate Pharmacovigilance Remote Job Opening – Pharma Apply Online. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
