Abhijat Bhatnagar
Summary
Accomplished Pharmacovigilance Professional with a proven track record at multiple workplaces, enhancing project profitability and client satisfaction through expert project management and resource allocation. Possessing over16 years of work experience in the pharmaceutical industry including 14 years of work experience in the end to end process in Pharmacovigilance (PV) and Drug Safety Industry. Skilled in leveraging multiple safety databases for safety surveillance, demonstrating exceptional leadership and complex problem-solving abilities. Achieved significant process improvements, ensuring optimal team performance and compliance with regulatory standards. Possess expertise in the transition, set up and management of pharmacovigilance processes like alliance management, PV compliance and PV analytics. Expert in monitoring (KPIs/Metrics for submission/ quality compliance for various parameters including but not limited to Individual case safety reports (ICSRs), Aggregate Reports, Safety signals, RMPs, Regulatory Intelligence for drugs and devices, PV Reporting Requirements, PV Agreements/ Safety Data Exchange Agreement (SDEAs).
Overview
17
17
years of professional experience
1
1
Certification
Work History
Pharmacovigilance Manager
ICON Clinical Research
09.2022 - Current
- Provides technical oversight of the generation of project plans such as but not limited to Safety Management plans (SMP), or SAE Reconciliation plans, in close cooperation with project team during set-up phase.
- As a project manager responsible for generating and approving project invoices. Present financial metrics for the project in the steering committee meeting. Maintaining project profitability. Creating and updating the project data in sales force.
- Liaises with other functional managers to ensure consistency of safety management approaches within the company.
- Reviews Pharmacovigilance (Reporting) Associate, Pharmacovigilance (Reporting) Specialist and/or Pharmacovigilance Assistant, Pharmacovigilance (Senior) Project Manager and Pharmacovigilance Project Lead, Pharmacovigilance Assistants, group-related project tasks; provides leadership in the delivery of related services to clients.
- Ensures that staff fulfill their responsibilities in accordance with company and/or client QMS, policies, procedures, and SOPs, as applicable.
- Supports the development and implementation of Pharmacovigilance training modules.
- Recommends and supports implementation of performance and productivity improvements within the assigned service area to ensure optimal utilization of billable staff.
- Performs metric collection and data analysis to support company efforts for continuous improvement in policies, procedures, and business processes.
- Identifies and implements process improvements through review of SOPs, processes; recommend improvement plans to senior management. Ensures staff performance and career development.
- Assists with bringing new business opportunities to the company and maintaining existing clients’ relationships for repeat business.
- Interacts with clients and participates in client meetings as necessary to support and maintain new business.
- As assigned, participates in business development initiatives, including presentations and proposal development. Ensures that timely and accurate information is submitted on all proposal efforts.
- Supports direct reports and senior management during audit preparation and conduct. Responds to audit findings as needed. Prepares Standard Response letters, including conducting literature search, article summary etc.
- Responsible for vendor management (e.g. LP Pharmacovigilance). Supports Qualified Person for Pharmacovigilance as required.
- Provided successful completion of projects on-time, within budget limits and with approved quality levels to support achievement of the department’s overall financial and quality goals and objectives.
- Develops, implements, and monitors profitability, objectives, metrics of assigned group of direct reports. Identifies and implements improvements of processes within the assigned service are through review of project specific plans and their implementation; recommends improvement plans to project.
- Manages resources and resource projections to ensure project teams are consistent with client needs, expectations, and contractual obligations.
Drug Safety Operations Manager
Quinecsa (Biloclinica) PVT LTD
04.2021 - 08.2022
- Ensure effective functioning of all PV deliverables in compliance with client agreement, contract, local and global regulatory guidelines.
- Responsible for quality, workload, change, compliance, and document management across of all PV deliverables.
- Provide regular reporting on project metrics, status of deliverables and risk/issues with the associated management plan to client.
- Management level liaison between the client relations representative and the project delivery team.
- Lead and direct cross-functional team leaders to optimize performance and utilization of project team members.
- Manage project and resource allocation within the PV department. Work with HR and recruitment to ensure timely mobilization of manpower.
- In collaboration with quality assurance, ensure that project team members are appropriately trained on all project SOPs, guidelines and documents as required.
- Coordinate and manage administrative project issues, delegate tasks and responsibilities to appropriate personal.
- Manage deviations and CAPA’s, support inspection readiness and participate in audits.
- Setting annual performance goals and conducting performance reviews, administering salary changes, bonus payouts and promotions.
Manager Pharmacovigilance
Mitocon Biopharma
06.2019 - 02.2021
- Coordination and supervision - coordinate, manage and monitor workings of various processes in the organization.
- Responsible for project management activities for ICSR and aggregate departments.
- Production - coordinate and monitor the work of various sections involved in production, monitor performance, and implement improvements with leads. Provide technical support where necessary.
- Facilitate coordination and communication between clients & and Mitocon.
- Ensure adherence to output targets at desired quality levels.
- Work with PV team on continuous process improvements in the field of safety surveillance, Clinevo database establishment, SOPs, guidance documents, templates, tools, upgrades.
- Strategic input – liaison with senior management. Assist in development of strategic plans for operational activity.
- Recruit and reward high performing individuals to meet goals. Facilitate resource evaluation needs across sites.
- Encourage practical applications of new ideas and formulate decisions and prioritize implementation of enhancements.
- Participated in several internal and external audits to check for appropriate controls in the process. Documented audit findings and helped in establishing guidelines for being compliant with data protection laws and regulations.
- Contribute to development of signal detection strategy for post marketed products.
Assistant Manager
Pharmalaex Pvt LTD
01.2016 - 06.2019
- Supervised day-to-day operations to meet performance, quality and service expectations.
- To perform literature surveillance for the clients in databases like Embase and Pubmed.
- Ensure team members receive the necessary training to perform their job functions effectively and consistently within regulations.
- Leads safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs) according to the agreed process and timelines.
- Reviewed CCDS/RSI and involved in its archiving.
- Understand and work to the current divisional/departmental SOP’s and WP’s, ensuring deviations are documented appropriately. Propose new and revise current procedures as appropriate.
- Participate in development and continuous improvement of processed and workflow including SOPs, trackers, task descriptions, narrative templates, coding and assessment conventions and job descriptions.
- Ensuring 24hours TAT compliance in NIS safety case follow-up process.
- Client interaction, which includes addressing client queries and client specifications.
- Participate in development and continuous improvement of processed and workflow including SOPs, trackers, task descriptions, narrative templates, coding and assessment conventions and job descriptions.
- Managing the workflow to meet the regulatory timelines for the submission of the ICSRs for different clients. To perform medical review of ICSRs.
Subject Matter Expert (Pharmacovigilance)
Accenture
11.2012 - 01.2016
- Mentored junior team members, contributing to their professional growth and development.
- Established best practices for knowledge sharing, fostering a culture of continuous learning and improvement.
- Developed effective training materials for diverse audiences, resulting in improved skillsets and increased job satisfaction.
- Streamlined processes to increase efficiency, enabling teams to complete tasks ahead of schedule.
- Comprehensive knowledge in handling Individual Case Safety Reports (ICSRs). Gained experience and expertise in handling all sorts of ICSRs.
- Well versed with regulatory requirements and reporting timelines for submission of Serious Adverse Events and Adverse events to FDA, MHRA and EMEA.
- Hands-on experience in MedDRA, WHO drug dictionary and knowledge of ICD coding.
- QC the processed cases by the team and release them in each day to meet the regulatory timelines.
- Supervise the workflow of staff in the pharmacovigilance department for both post-marketing and clinical studies.
- Contribute to development of signal detection strategy for post marketed products.
- Mentor and train the team on new regulations to deliver high quality of ICSRs especially literature cases.
- Provides subject matter expertise (SME) in the therapeutic area and across multiple products. Handled social media cases and cases reported through websites and patient support programs and PMOS.
- Prepare the documents for the work progress of the team (including handling of CAPA and action plans to ensure the delivery of the quality and productivity of the team).
- Organized quality workshops and created quality circles to improve the quality of Individual Case Safety Reports (ICSRs).
- Tracking of projects and metrics. Generates follow up query for applicable ICSRs.
Pharmacovigilance Associate
APCER PVT LTD
09.2010 - 11.2012
- Authoring and contributing to numerous PSURs (6 monthly, 3 yearly and renewal PSURs with Addendum reports) and ensured timely delivery of information for aggregate reports and other regulatory documents as requested.
- Processed Initial Case Safety Reports (ICSRs) based on conventions and rules and entering them in the data base (Clintrace and Arisg).
- Triaged a case based on seriousness and reportability based on timelines and type of cases.
- Provided training to new joiners.
- Determine if appropriate case follow-up was considered or not. Conducted follow-up activities when needed.
- Developed and maintained expertise of all assigned products, of applicable corporate, Policies and local regulations, guidelines, Standard Operating Procedures and writing practices, of data entry conventions, and of search functions in the safety database.
Quality Assurance Executive
Penta Biotech PVT Ltd
02.2008 - 08.2009
- Responsible for preparing all the documentations related to quality assurance.
- Responsible for conducting all the timely calibrations and validations required for pharmaceutical industry.
- Responsible for ensuring the in-house quality for different pharmaceuticals.
- Provided training to new joiners.
- Introduced the control room system to store samples.
- Manufactured tablets, capsules, and dry syrups.
Education
Post Graduation Diploma in Clinical Research & Mgt - Clinical Research And Management
Clinical Research Education And Management Academy
India09.2010
Bachelor Of Pharmacy - Pharmacy
JSS College Of Pharmacy
India12.2006
Skills
Pharmacovigilance process
Project Management
Resource Management
Pharmacovigilance Operations
Team Leadership
Meddra Coding
Verbal and written communication
Complex Problem-Solving
Artificial intelligence Systems: PVAI tool for Literature surveillance
Safety Databases: ARGUS, ARISg, Clinevo, Clintrace, Pharmacovigilance one etc
Project Finance
Pharmacovigilance Trainer
Certification
Certified Lean Six Sigma Black Belt holder by MSME (Ministry of micro, small and medium enterprises).
Timeline
Pharmacovigilance Manager
ICON Clinical Research
09.2022 - Current
Drug Safety Operations Manager
Quinecsa (Biloclinica) PVT LTD
04.2021 - 08.2022
Manager Pharmacovigilance
Mitocon Biopharma
06.2019 - 02.2021
Assistant Manager
Pharmalaex Pvt LTD
01.2016 - 06.2019
Subject Matter Expert (Pharmacovigilance)
Accenture
11.2012 - 01.2016
Pharmacovigilance Associate
APCER PVT LTD
09.2010 - 11.2012
Quality Assurance Executive
Penta Biotech PVT Ltd
02.2008 - 08.2009
Post Graduation Diploma in Clinical Research & Mgt - Clinical Research And Management
Clinical Research Education And Management Academy
Bachelor Of Pharmacy - Pharmacy
JSS College Of Pharmacy
Certified Lean Six Sigma Black Belt holder by MSME (Ministry of micro, small and medium enterprises).
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