Lead Pharmacovigilance Specialist
Location
Noida | India
Job description
The Lead 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. Also involve in process improvement/innovation projects, mentor and guide the junior team members etc
What you will need:
- Master's Degree in life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics etc.)
- At least 7 years of experience in team management, and stakeholder management along with reviewing biomedical literature for adverse event reporting OR equivalent combination of education and experience
- Writing skills to support the creation of succinct, accurate, and precise summaries and working knowledge of biomedical terminology, drugs, and therapeutic areas.
What will you be doing in this role
- Mentor and support the junior team members. 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.
- Involve in process improvement projects, stakeholder management etc
- Write brief narratives summarizing the ICSR criteria and other potentially safety-relevant information in each article.
- Demonstrates understanding of client's drugs 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.
- 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
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.
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