Komala B
PV Quality Management Associate |Sr. Pharmacovigilance Specialist| Case Processing |SAE Reconciliation |Quality Review |Audit & Inspection| Vendor Management |ICSR & Regulatory Submissions| Training &Mentoring| CAPA|
- Role
- Pv Quality Management Associate, Cspv at Daiichi Sankyo US
- Location
- Edison, NJ, US
- LinkedIn followers
- 500 followers
About Komala B
Senior Drug safety specialist with over 6.5 years of experience in Pharmacovigilance and Drug Safety. My career has focused on ensuring the safety and compliance of pharmaceutical products, and I’ve had the opportunity to work across a wide range of cases, including clinical trials, spontaneous reports, literature reviews, and Post marketing cases.I specialize in managing SUSAR cases and performing SAE reconciliation to ensure accurate reporting and compliance with global regulatory standards. I’ve worked extensively with tools like ARGUS, ARISg, MedDRA, and WHO-DD and have a deep understanding of FDA, MHRA, and GCP/ICH guidelines. Whether it’s processing cases, determining the seriousness of events, or writing clear and concise narratives, I’m committed to delivering high-quality work that meets both regulatory standards and organisational goals.Assisted in the preparation of aggregate reports (PSURs, PBRERs, PADERs, DSURs) by generating line listings, writing clinical narrative summaries, and performing signal detection and risk management activities.Additionally, I have supported CAPA investigations, audits, and inspections, and contributed to ensuring process improvements for better compliance and performance.Collaboration has always been a core aspect of my role. From managing vendors and resolving queries to working closely with cross-functional teams and pharmaceutical partners, I enjoy building relationships that drive results. I’m also skilled at balancing deadlines with accuracy and attention to detail, which helps me tackle challenges and deliver successful outcomes.Above all, I’m passionate about improving patient safety and supporting therapies that make a difference in people’s lives. Let’s connect if you’re interested in discussing how my skills and experience can support your organisation\'s goals.
Experience
Pv Quality Management Associate, Cspv
Mar 2025 — Present · Basking Ridge, NJ, US
Education
Gulbarga University
Bachelor of Science, Biotechnology
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