Deputy General Manager, Research & Development | Elite Safety Sciences | Gurgaon
- Led a diverse team of drug safety experts on a cutting-edge lung transplant clinical study, resulting in successful study completion with the potential to double suitable donor lung availability.
- Championed a team of drug safety physicians overseeing adverse event reports for a range of marketed and investigational drugs.
- Executed meticulous project plans and led the team to ensure compliance with regulatory standards, culminating in an unblemished record of zero critical findings in 8+ audits and inspections over 5 years.
- Directed hiring initiatives encompassing candidate sourcing, interviews, and selection with a focus on company values and objectives.
- Streamlined onboarding of 50+ professionals, yielding a significant reduction in time-to-fill positions and acquisition of high-calibre talent.
- Led continuous improvement initiatives to enhance operational efficiency and overall drug safety processes, realizing a 10% reduction in project costs and enhancing deliverable quality by streamlining adverse event reporting.
- Developed and executed training programs on pharmacovigilance, regulatory guidelines, and safety reporting, yielding a remarkable 25% surge in team productivity (cases analyzed) for processing patient adverse event reports.
- Initiated early signal detection activities to look for serious adverse events through rigorous analysis of clinical trial data for a novel anti-cancer drug, facilitating risk mitigation, ensuring patient safety and successful regulatory approvals.
- Performed medical evaluation and analysis of safety reports on a breakthrough drug for a life-threatening lung disease. Handled a substantial workload of 500+ adverse event reports per month, ensuring exceptional data accuracy and 100% compliance with US FDA and EMA's adverse event data reporting timelines.
Senior Safety Physician, Research & Development | Sciformix Technologies | Pune
- Reviewed patient safety reports and evaluated literature articles on multiple cardiovascular drugs for potential safety concerns. Played a critical role in reducing a substantial backlog of 100+ outstanding scientific literature articles in a record 3-week period.
Senior Drug Safety Physician, Research & Development | Parexel International | Chandigarh
- Led an 8-member team of drug safety physicians in delivering medical review services for 100+ drugs, both marketed and investigational, for a global pharmaceutical client.
- Played a crucial role in promptly detecting critical safety issues related to a cardiovascular drug's usage in diabetic patients. Facilitated the addition of identified safety issues to the warning section of the drug's label, ensuring patient safety and regulatory adherence.
- Contributed to cross-functional meetings by presenting safety findings and recommendations, leading to enhanced safety protocols for ongoing trials of an anti-cancer drug. Played a key role in concluding clinical trials and helping secure regulatory approvals for drug launch in the European market (targeting a ~20% market share upon entry).
Medical Officer, Healthcare Solutions Professional | Gangaputra Hospital| Jind
- Managed medical units and provided optimal patient care by overseeing treatment plans, monitoring progress, and collaborating with multidisciplinary teams to deliver holistic health care, under the supervision of the referring physician.