Geetanjali Jain
Safety Scientist @Cognizant
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WORK HISTORY
Safety Scientist @Cognizant
Conducting signal detection activities as per agreed strategy, perform signal validation and signal assessment/evaluation analysis for proactive and timely identification of signals such as characterization of risks- Keeping track of ongoing signals along with full documentation-Organizing and leading the safety management team (SMTs) meetings- Acting as literature lead to conduct ongoing literature safety surveillance for marketed and investigational products- Assisting with identification of ICSRs from literature, evaluation of events of special interest as well as aggregate data and/or signal detection relevant review-Authoring and/or contributing to literature deliverables for aggregate reports and/or signal management activities meeting strict regulatory timelines-Effectively and clearly communicating the technical, medical and scientific information in critical submission and internal PV documents in order to deliver high quality reports within the specified timelines-Collaborating cross functionally for continuous improvement of standards and best practices.
EDUCATION
Himachal Pradesh University, Shimla
Bachelor of Pharmacy (B.Pharm.), Pharmacy
Laureate Public School, Shimla
Senior Secondary, Science
G.A.V. Public School, Kangra
Higher Secondary
Shoolini University of Biotechnology and Management Sciences
Master of Pharmacy, Pharmacology
SKILLS
ABOUT GEETANJALI JAIN
Dedicated pharmacovigilance expert with 10+ years of experience in ensuring drug safety through strategic risk assessment, audit preparedness, and regulatory compliance. Proven expertise in leading the development and review of critical safety documents (PBRERs/PSURs, HHEs, Addenda to Clinical Overviews, PADERs) while driving global standards (ICH, FDA, EMA) as well as adept at literature reviews, ongoing safety surveillance, and transforming complex medical data into actionable insights. Strong leadership in mentoring and training teams, with proven ability to orchestrate Safety Management Team (SMT) meetings while demonstrating effective presentation skills. Committed to optimizing pharmacovigilance processes that safeguard patient health and regulatory integrity.
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