Jayaraman Venkatachalam
Bangalore
Summary
Pharmaceutical professional with 14+ years of experience, including 11.5 years in End-to-End Pharmacovigilance (ICSR) and 2.9 years in Clinical Trial Operations. Currently serving as General Manager for End-to-End ICSR Case Processing at Accenture, leading 200+ PV Associates. Member of the Accenture ICSR Processing CoE (Center of Excellence): Focused on centralizing PV tools, optimizing processes, and driving automation initiatives (AI/ML). Member of the Accenture Regulatory Intelligence CoE (Center of Excellence): Specializing in monitoring regulatory changes in Pharmacovigilance and assessing their impact on Accenture’s Pharmacovigilance SOPs.
Overview
15
15
years of professional experience
Work History
General Manager
Accenture private limited
Bangalore
06.2022 - Current
- Provide guidance, mentorship, and support to team members, fostering a culture of accountability, collaboration, and continuous learning
- Set clear performance expectations and objectives, and regularly assess team performance against key performance indicators (KPIs) and service level agreements (SLAs)
- Oversee the end-to-end process of individual case safety reporting, ensuring timely and accurate submission of adverse event reports to regulatory authorities and other stakeholders
- Maintain project management oversight on aggregate safety reports (e.g., Periodic Safety Update Reports, Development Safety Update Reports) in compliance with regulatory requirements
- Maintain oversight on monitoring and analyses of safety data to identify potential safety signals, leading the investigation and assessment of safety signals as appropriate
- Ensure compliance with pharmacovigilance regulations, guidelines, and internal policies and procedures
- Implement quality management systems and processes to maintain high standards of data integrity, accuracy, and completeness in pharmacovigilance activities
- Collaborate with cross-functional teams to address any compliance or quality issues and drive corrective and preventive actions (CAPAs) as needed
- Build and maintain strong relationships with client and internal key stakeholders, facilitating effective communication and collaboration to support project level pharmacovigilance activities
- Identify opportunities for process optimization, automation, and standardization to enhance efficiency and scalability of project level pharmacovigilance operations
- Lead or contribute to continuous improvement initiatives, driving innovation and best practices adoption within the pharmacovigilance function
- Ensure optimum deployment of people and resources to deliver business results
- Manage the Team Leads/ Tower Leads in terms of the group achieving their individual and group performance targets; manage any issues arising out of those on a daily basis
- Work with process owners to proactively resolve differences
- Define issues, organize cross project sub-teams, and review recommendations
Deputy General Manager
Accenture private limited
Bangalore
06.2016 - 05.2022
- Assigning cases to team members and ensure on prioritization based on LP and regulatory timelines
- Assist in representation of Global Safety and Pharmacovigilance group at project team and client meetings
- Conduct daily team huddle and discuss on latest updates, quality and other relevant metrics
- Communicating on issues related to case processing, conventions, client findings and other issues that would impact quality or timelines
- Tracking deviations, assessing root cause for errors and implement corrective actions
- Attend client meetings to discuss on process, quality and TAT compliance
- Tracking deviations, assessing root cause for errors and implement corrective actions
- Mentor colleagues in area of expertise
- Assist with SAE/BP/LM reconciliations, SUSAR/comparator SUSAR team
- Tracking PBRER/PADER/DSURs reports
Senior Drug safety associate
Accenture Private Limited
Chennai
08.2013 - 05.2016
- Reviewing and evaluating adverse event reports (AERs) to determine if they meet regulatory reporting requirements
- Entering and maintaining adverse event information in safety databases
- Narrative writing
- Assisting in the preparation of safety reports to be submitted to regulatory agencies
- Monitoring safety literature to stay current on the latest safety information related to the company's products
- Collaborating with other departments such as clinical research, regulatory affairs, and pharmacovigilance to ensure compliance with safety regulations and guidelines
Clinical Operations Specialist
ICON Clinical Research
12.2011 - 07.2013
- Assist Clinical Team Lead (CTL) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
- Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- Assist with periodic review of study files for accuracy and completeness
- Assist CTLs with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
- Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
Senior Clinical Research Coordinator (Senior CRC)
Life Care Clinic and Research Centre
Bangalore
07.2010 - 07.2011
- Prepare site for SIV and Coordinate Monitoring and Site Audit
- Reporting AE and SAE and Solving DCF
- Assist in the ICF process, screening & enrollment
- Data collection procedures in adherence with the study protocol and in accordance with ICH-GCP guidelines
- Clinical Data Entry from Source Documents to e-CRF
- IVRS Caller Access, Scheduling Subject Visits
- Handling Discrepancy Management
Education
M.Pharmacy - Pharmacology
C L Baid Metha College Of Pharmacy
Chennai06-2010
B.Pharmacy - Pharmacy
JKKN College of Pharmacy
Namakkal 08-2007
Skills
- End-to-End ICSR Processing
- Interventional clinical trials
- Compassionate Use Programs
- Post-Marketing Studies
- Patient Support Programs
- Market Research
- REMS
- Spontaneous Reports
- Literature Review
- Disease Registries
- Poison Control Centres
- Health Authority ICSR Downloads
- Social Media Monitoring
- Legal Case Management
- SUSARs and SAE Reconciliation
- Pharmacovigilance Agreements
- SAE Management
- ICSR Submissions
- AERS
- Argus Safety Database
- ARISg Safety Database
- LSMV Safety Database
- Rave Safety Data Exchange Platform
- Regulatory Query Handling
- Internal Audits
- External Audits
- Deviation Management
- ICSR Regulatory Guidelines
- SOP Development
- Safety Data Migration
- Safety Database Configuration
- Regression Testing
- Smoke Testing
- Project Management
- KPI Monitoring
- SLA Management
- Resource Management
- Client Relationship Management
- Budgeting
- Forecasting
- Change Management
Languages
- English
- Tamil
- Kannada
Accomplishments
- Awarded “Grade of Excellence” for the project work during the M. Pharmacy
Awarded Best Outgoing Student for the batch of 2003-2007, Gold Medal for overall Academic Proficiency
Awarded “Grade of Excellence” for the project work during the B. Pharmacy
Awarded College Rank holders in University Examination (B. Pharmacy) during the year of 2004, 2005, 2006 and 2007.
Awarded 'Best Clinical Research Coordinator' from Novo Nordisk in year of 2011
Awarded 'Best Talent' by Clinical Project Managers in the year 2012
Awarded 'Numero Uno' in the year 2013 within six months of joining Accenture
Received client recognition for the completion of the HA CAPA project in the year 2017
Awarded 'Team Lead Process Pro' in the year 2018
Awarded 'PV Best talent' in year of 2019 where more than 50 Professionals nominated
From 2020, I have been a member of Accenture's ICSR Processing COE and Accenture's Regulatory Intelligence COE
Represented Accenture in DIA Conferences
Disclaimer
I hereby declare that all the details furnished above are true and correct to the best of my knowledge and belief.
Timeline
General Manager
Accenture private limited
06.2022 - Current
Deputy General Manager
Accenture private limited
06.2016 - 05.2022
Senior Drug safety associate
Accenture Private Limited
08.2013 - 05.2016
Clinical Operations Specialist
ICON Clinical Research
12.2011 - 07.2013
Senior Clinical Research Coordinator (Senior CRC)
Life Care Clinic and Research Centre
07.2010 - 07.2011
M.Pharmacy - Pharmacology
C L Baid Metha College Of Pharmacy
B.Pharmacy - Pharmacy
JKKN College of Pharmacy
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