Abhijeet Shankar Kulkarni

As a pharmaceutical professional with a master's degree in Pharmaceutical Science (with Clinical Research) from London and 10+ years of experience in Pharmaceuticals, Clinical Operations, and Pharmacovigilance, I bring a wealth of knowledge and adaptability to the table. With a background in pharmaceutical sales and research laboratory work for the UK's National Health Service (NHS), I have worked in Europe, Asia, and Canada/US. My skills include exceptional communication, organization, problem-solving, and knowledge of international regulations and clinical trial databases.

NIIT, Canada Project delivery lead/ Training consultant October 2015 – Present

• As a project delivery lead/training consultant, I am responsible for overseeing the NIIT Centre of Excellence (CoE) for Veeva projects and managing a team of nine managers and department heads.
• I work with business partners to manage project activities such as scope management, budget adjustment, content management, and trainer management, and I provide upskilling opportunities for new and existing trainers and staff.
• I manage client-specific training workshops across the world for clinical operations, data management, and pharmacovigilance staff, conducting assessments and ensuring compliance for both trainers and participants.
• I assist Clinical Research Associates (CRAs) and Clinical Leaders (CLs) in achieving study-specific deliverables for clinical sites, provide local knowledge through various discussions, and guide and contribute to Clinical Study Teams (CSTs) and Trial Management Teams (TMTs).
• I anticipate risks and implement mitigation strategies, manage study team assignments, accountability, and resource requirements, and train/mentor key clinical operations staff for onsite quality visits.
• I develop, facilitate, and lead project specific Veeva training for records and information management (RIM), trial master file (TMF), and pharmacovigilance (PV).
• I am also a certified trainer for all AMGEN clinical databases.

01-June-2015 to 02-Oct-2015

• As a project manager (healthcare consultant), I supported the senior consultant in designing and implementing health projects and internal medicinal research, managing a team of 25 employees.
• I supported internal audit and inspection activities and contributed to Corrective and Preventive Actions (CAPAs), including leading the resolution of issues when necessary (e.g., vendor management).
• I oversaw the study lifecycle, including planning, submissions, and approval stages of protocol amendments during the maintenance phase of the study.
• I was accountable for strategic planning and decision-making at the study level in line with program objectives and accountable for issue resolution.
• I utilized negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional study team performance and accountable for effective study team operations.
• I provided training to internal team members and maintained training transcripts and related documents.

Roles and responsibilities (Program lead and a regional trainer):

• Collate, assess, and dispatch comprehensive safety reports (PSUR and DSUR) to relevant recipients (including regulatory bodies) using both E2B and non-E2B methods.
• Oversee and organize the recording of study initiation data in the database, verifying accuracy and completeness.
• Maintain a record of training sessions conducted for the local team members involved in the Pharmacovigilance submission team.
• Update all PV safety data trackers in a timely manner and forward them to the project manager for compliance review and statistical analysis.
• Ensure conformity with health and investigational new drug (IMP) standards, and promptly report any non-compliance to regulatory bodies while recommending corrective actions.
• Collaborate on the drafting of Safety Data Exchange Agreements (SDEAs) and Service Level Agreements (SLAs) for designated studies.
• Keep the Pharmacovigilance System Master File (PSMF) up to date with information such as QPPV details, organizational charts, service agreements, vendor details, contracts, quality information including CAPA/Deviation reports, etc.
• Create, review, and maintain the Safety and Medical Management Plan (SMMP) and Expedited Safety Reporting Plan (ESRP) for clinical trials and post-marketing projects.
• Participate in audits conducted by clients and inspections by regulatory bodies such as the MHRA. Report healthcare and safety issues to clients and share with regulatory authorities.

Roles and responsibilities (Subject Matter Expert and Project lead):

• Complete case processing including triage, data entry, labelling assessment, narrative writing, and quality check of SUSAR and ICSR.
• Responsible for quality checking on database like Oracle AERs, ARISg and Argus and provide the training, if necessary, per the case handling SOPs. 
• Keep records of trainings with local team members who are part of Pharmacovigilance submission team.
• Responsible for answering queries raised by the clients, internal and government agencies, and private ethics committees. 
• Responsible of reviewing the safety documents like SMMP, ESRP, annual and periodic safety reports.
• Active participation in module development, training program, mentoring program and regular training sessions to internal and external team members.
• As the leader of a global cross-functional project team, this role is responsible for delivering the project on time and to a high standard, meeting all contractual obligations.
• The primary point of contact with the customer, this position will communicate regularly on project progress and governance. 

• Follow up with investigator sites on the status of study documentation and resolve any issues promptly.
• Serve as the main source of study information and lead study-level status reporting in line with organizational norms and expectations.
• Prepare, validate, and submit regulatory documents such as completed IIP, IRB approval forms, and FDA 1572 revisions for internal regulatory approval within the required timelines.
• Maintain investigator payment documentation and ensure the quality control of trial master file documents.
• Develop record-keeping systems, indexes, guides, and procedures for archival research and the retention and destruction of records.
• Collaborate with internal and external key stakeholders through effective communication and resolution management, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the Site Activation Management Plan.
• Provide ongoing updates and reports to various levels of the organization, including study team and senior level colleagues.
• Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines, and project plans with project-specific information.

• As a clinical research associate on a Pfizer studies, where my main responsibilities were performing quality control of essential trial documents per the country specific regulations.
• preparing record-keeping systems, indexes, guides, and procedures for archival research and for the retention and destruction of records
• Following study specific SOPs, preparing trial documents for auditing purposes, assisting with the setup and maintenance of the trial master file and investigator site files. 
• In Pfizer I was assisting CPM and performing study team roster setup with updating of RAF (Risk assessment form). 
• My focus was on completed and on-going studies phase 0-IV for maintenance of preliminary feasibility documentation and ensuring all the regulatory requirements.
• Creating test data and performing testing to ensure the validity of clinical databases and raising data queries to ensure quality and consistency of clinical trial databases.
• Iworked with management to ensure that all projects set up activities are clearly defined, communicated, tracked, and delivered.
• Worked with management to ensure that project deliverables are planned out sufficiently in advance to ensure high standards are maintained in terms of accuracy, completeness, and timelines.

April 2010 – June 2010 

• Support research team to design and implement health projects and internal medicinal research. 
• Perform evaluations and assessments of laboratory research programs.
• Communicate with internal and external stake holder. Create and maintain Standard operating procedures in laboratory along with internal policies.
• Provide trainings to internal team members. If required, supervise undergraduate students working on their respective research projects.
• Review literatures and other documents to carry out required research programs. 

Additional Qualifications/Skills

• Proficiency in Clinical Systems - Hands-on experience with all databases used in Clinical Operations (CTMS, Inform, Clinical Analytics, Wingspan), Data Management (Medidata Rave, Oracle Clinical, People Soft, Inform), and Pharmacovigilance (ARISg, Argus, ADVENT, and Oracle AERs).
• VEEVA Expertise - Skilled in the use of the Clinical Operations Suite, RIM Suite, Quality Suite, Pharmacovigilance Suite, and VEEVA CRM Suite.
• Successful completion of ICSR (Eudravigilance Submission) training conducted by EMA to acquire Responsible Person licensure.

Oncology In depth therapeutic knowledge in Cell and Gene, Immuno-oncology, and Targeted Therapies, First in Human and Pediatric Oncology.

Cardiovascular, Renal and Metabolic

Comprehensive understanding of the pathophysiology, diagnosis, and treatment of Cardiovascular, Renal, and Metabolic Diseases.