Ravi Singh

Pharmacovigilance medical writer with 12 years of experience in writing safety evaluation reports(SERs)/Adhoc safety reports, health authority responses, literature reviews, clinical overviews (COs). Authored more than 300 reports. expert in end-to-end signal management, ensuring compliance with global safety regulations. Proven ability to synthesize data from multiple sources and. Collaborative team player with excellent communication skills and therapeutic area expertise in Oncology, Endocrinology, Biosurgery, Haematology, Infections and Infestations, Dermatology, Cardiovascular, Rheumatology, Immunology/Autoimmune Diseases, Metabolic Disorders, Virology, and Psychiatric and CNS Disorders. Reliable Manager demonstrating high level of ownership and initiative. Possessing exceptional work ethic and desire to go above and beyond to exceed company expectations. Offering knack for building productive working relationships. Successful in fast-paced, deadline-driven environments to manage goals and team development. History of thriving in team-oriented environments.

Himachal Pradesh State Dental Council

• Fluent in English
• Fluent in Hindi

• End-to-end signal management: signal detection, prioritization, validation, evaluation, analysis, and assessment
• Authoring comprehensive signal evaluation reports (SERs)
• Collaborating with global safety officers for safety committee management, data analysis, and ad hoc requests
• Responding to safety inquiries from internal and external stakeholders
• Reviewing medical and scientific literature for safety information
• Monitoring compliance with relevant global safety regulations and guidelines
• Preparation of aggregate reports, including PSURs, PBRERs, and aCOs
• Medical writing expertise: clinical study/trial review and literature assessment
• Managing Individual Case Safety Reports (ICSRs): triage, data entry, coding, case summaries, causality assessment, and company comments
• Proficiency in Medical Dictionary for Regulatory Activities (MedDRA)
• Resolving issues related to ICSRs processing and achieving timely submissions to regulatory authorities
• Training and mentoring PV scientists on safety science activities
• Conducting quality checks of SERs in accordance with SOPs and regulatory requirements