Dr. Abhishek Kaler

• Spearhead comprehensive Safety Services talent lifecycle management, encompassing strategic recruitment, professional development, and performance optimization

• Cultivate high-performing teams through mentorship, fostering synergy, and ensuring adherence to regulatory standards

• Establish and maintain strategic client partnerships, enhancing satisfaction and trust through efficient and professional service delivery

• Execute advanced responsibilities aligned with senior-level expertise, leveraging guidance to drive organizational objectives

• Develop and evaluate metrics to identify need for improvement efforts in processes, staff educational activities, or to better meet client needs.

• Attend internal/external audits as required; respond to audit reports and follow-up on any issues highlighted

• Provide technical leadership to team ensuring data presented in the documents follow applicable regulatory guidelines, SOPs, and goals of submission

• Performed peer review and quality review on behalf of client for aggregate reports.

• Responsible for writing scientific/medical reports to communicate clearly, accurately, and comprehensively to healthcare regulatory agencies. These include preparation of drug safety and efficacy reports to bridge information between public and professionals of healthcare and pharmaceutical industry thus ensuring safe and effective use of a medicine.
• Ensuring that all documents are technically and mechanically accurate, consistent with style guidelines, and consistent with regards to clarity, flow, organization, completeness, accuracy, readability, and/or appropriateness.
• Lead Author for more than 60 Development Safety Update Reports (DSURs).
• End to end authoring of high quality DSURs that comply with internal standards and applicable regulatory guidelines along with stakeholder's management.
• Lead planning meetings, develop strategies, plan resources, set goals and coordinated with the team of medical writers to meet the project timelines. Interact and effectively communicate internally and cross-functionally in a highly matrix environment.
• Managed critical report timelines including pre-kick-off, kick-off meetings, comment resolution meetings with client and act as point of contact for all deliverables for assigned project.
• Provide guidance and mentoring to the team of 15 medical writers.
• Subject matter expert in bid defense meetings for medical writing requests.
• Training representative for developing and maintaining the training curriculum. Supervised and managed activities that include, calculating and ensuring the team's training compliance on monthly basis (internal as well as client specific).
• Performed project management activities (maintaining the project level documents like test scripts, onboarding/off-boarding records, Team list, Back-up list, Organization charts, resource distribution).
• Interviewed candidates and was involved in the induction related activities of newly onboarded users.
• Provided support for management of quality issues and non-conformances.

• Authoring and coordinating the overall process for preparation, review, approval and distribution of DSURs associated with assigned products in accordance with worldwide regulatory requirements.
• Led study discussions for DSURs as the single point of contact together with strategizing, assessing, writing, and reviewing safety sections.
• Identifying new safety information from trials, literature, and other sources for inclusion in the report.
• Ascertaining that consistency is maintained among safety & non-safety sections.
• Co-authoring safety related activities for clinical trials: Review of protocols, statistical analysis plan, safety content of Reference Safety Information and Clinical Study Reports, aggregate safety data review.

• Lead Author for more than 50 Periodic Benefit-Risk Evaluation Reports (PBRERs) and co-authored around 20 PBRERs and managed assigned projects from kick-off to delivery.
• Expertise in Preparing the safety and efficacy sections of PBRERs in accordance with client requirements/conventions and Standard Operating Procedures.
• Proficient in writing the Benefit Risk Evaluation (BRE) section for inclusion in the aggregate reports.
• Managed cross functional interaction (biostatisticians, regulatory, global/ local safety officers).
• Screening and review of literature search results (literature abstracts, articles, citations including clinical cases) for inclusion in PBRERs.
• Signal detection activities including triage, periodic review of line listings and literature reports.
• Handled client queries as the SME and assist in preparation and support of audits and inspections.
• Proof-read and detail-oriented quality review of the deliverables prepared by peer.

• Experienced in clinical trial reconciliation, clinical studies, trial review and scientific epidemiological literature reports.
• Performed the data review and evidence check process for Non-Interventional Programs.

• Authored around 200 CSR narratives and co-authored 10 clinical study protocols.
• Expertise in writing narratives for Clinical Study Reports (CSRs) which includes development of narrative templates, assessing outputs of clinical database and safety database, writing narratives and concatenating them for inclusion in the CSR per client and Regulatory requirements.
• Maintaining an excellent knowledge of the safety profile of assigned drugs, Reference Safety Information documents, aggregate reporting conventions and guidelines, clients' procedures and international drug safety regulations including ICH guidelines on safety and efficacy, New PV Legislations/GVP Modules, FDA guidelines, CIOMS.