Job Description
Senior Pharmacovigilance Specialist
Job Profile Summary
This position involves Biomedical Literature Searching in our team and requires knowledge of biomedical literature and searching databases such as MEDLINE, Embase and Biosis Previews. You will need broad knowledge of biomedical terminology, drugs, and therapeutic areas. In this role, you are responsible for conducting specialized complex research and analysis to produce quality search results for clients. Using your expertise, you will also have opportunities to share your knowledge through mentoring and coaching of other team members.
What you will need:
- Bachelor’s/Master’s degree in Pharmacy, Life Sciences, Nursing, Chemistry, Information Sciences, or related field. Advanced degree (e.g., PharmD, MD, PhD) preferred.
- At least 5 years of experience reviewing biomedical literature for adverse event reporting, with specific expertise in literature screening.
- Writing skills to support the creation of succinct, accurate, and precise summaries and working knowledge of biomedical terminology, drugs, and therapeutic areas.
- In-depth knowledge of pharmacovigilance principles, adverse event reporting requirements, signal detection methodologies, and risk assessment principles.
- Strong understanding of pharmacovigilance regulations and guidelines (e.g., ICH, GVP) and experience with regulatory submissions.
What will you be doing in this role?
- Develop and refine literature search strategies and methodologies to ensure comprehensive and systematic screening of scientific literature databases, including MEDLINE/PubMed, Embase, Biosis Previews, and other biomedical databases.
- Proficient in searching literature for NDA, PSUR, DSUR, AER, and client-requested searches to identify relevant safety information, including adverse events, safety signals, and emerging risks associated with assigned products.
- Supports the development and execution of a literature search training program that aligns with internal guidelines, industry best practices, and is flexible enough to include customer-specific directives. Helps the leads and Managers in the internal training of new recruits and organizes regular refresher training sessions for the entire team. Assesses the performance of trainees, keeps training records up-to-date, and ensures documentation is ready for audits.
- Analyses search requests from clients and designs and inputs search strategies that result in specific and accurate retrieval from commercial databases.
- Maintains an awareness of new drugs and new therapeutic categories, new disease entities, and changes in biomedical terminology in the published literature to provide for continuing responsiveness to department databases.
- Participates in assignment tracking, client communications, and reporting, as requested.
- Holds good knowledge of biomedical searching platforms such as Dialog, PubMed, or related platforms and understands how to apply thesauri such as MeSH and Emtree.
- Aids in addressing system-related issues of the hierarchies and their application in retrieval strategies.
- Co-operates with retrieval and abstract/index specialists on term assignments to confirm the appropriateness of solutions and instigates discussions of varying perspectives to ensure adherence to best practices.
- Establishes effective collaborations with customers during the pre- and post-sales process to comprehend specific procedures and receive training tailored to the customer’s needs.
- 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 and Noida) Hybrid work mode.
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.
