Dr. Atul Kumar Email & Phone Number

Karnataka, India

Bengaluru, Karnataka

•Responsible for medical review of aggregate reports•Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources to predict/establish the safety profile of marketed compounds to manage the risk to patients with minimal supervision.• Involved in all safety surveillance activities, including medical review of individual safety cases and signal detection evaluation.•Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for the evaluation of signals. Discusses results of data evaluation with the Surveillance Team and/or appropriate key stakeholders•Providing leadership to support project discussions with governance boards, including interactions with the Patient Safety Peer Review Committee. •Lead the safety strategy for regulatory communication and provide oversight of high-level documents to support submission activities•Provides medical input to deliver accurately and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data•Contribute to designing and reviewing the protocols for clinical trials, assuring that the overall scientific and medical content of all clinical programs including protocols are scientifically and clinically relevant. •Contributor to the preparation of various official and regulatory documents for Regulatory and other agencies, such as Safety and Annual reports, handling of responses to regulatory agencies regarding questions about complex clinical development issues (e.g., safety or efficacy)•Provides strategic input into responses to regulatory requests for local label deviations from the company core safety documentation.•Provides medical input to regulatory supporting documentation for labeling updates, license renewals, labeling, and regulatory responses

Mumbai Area, India

• Medical review of aggregate safety reports (PSURs, PADERs, and PBRERs).• Participate in ongoing safety surveillance and signal detection/analysis activities including aggregate data review /trend analysis (EVDAS, EMPIRICA database).• Participate to strategize and review safety assessments, risk/benefit evaluations, Risk management plans (RMPs), and other ad-hoc regulatory reports.• Contributed to authoring and reviewing of the clinical trial protocol, annual safety reports including SUSARs and SAEs.• Ensuring complete responsibility for all assigned deliverables in line with expected quality, compliance, and productivity SLAs and KPIs. Actively engage with the writing team to ensure quality and compliance SLAs are being met through coaching, mentoring, and timely feedback.• Establish an excellent working relationship with the client medical team and Managers/leads as required.

Navi Mumbai

• Report preparation [e.g., Periodic Safety Update Reports (PSURs), Addendum PSURs, Bridging Reports, PSUR Line Listings, US PADERs] • Quality checks of aggregate reports; Signal detection-related analyses and reports including cumulative analyses, issue event analyses, Drug Safety Reports, review of published literature and case listings; Vigilance over important/designated medical events;• Interaction with client personnel to discuss potential signals and issues detected with products; Support preparation and maintenance of Risk Management Plans;

New Delhi Area, India

• Medical Review of ICSRs in Argus for clients’ products.• Signal Detection of the ADRs with cases received for clients’ products and preparation of Drug safety reviews.• Literature search and drafting of narrative based on information received.• Causality determination (Relatedness) along with overall case assessment.• Provide inputs/ advice/ feedback to the Case processing team pertaining to medical judgment and medical queries.

New Delhi Area, India

Navi Mumbai

• Reviewing ICSRs reports verifying accuracy, consistency, and completeness of the information. Responsible for Company Causality assessment and Company Case Comment.• Handling of medical queries raised by the quality team.

Bengaluru Area, India