Summary
Overview
Work History
Education
Skills
Languages
Hobbies
Accomplishments
Timeline
Generic

BHARATH SUBHASH

Vijayawada

Summary

Pharmacovigilance Professional with 10 years of accomplishment in leading pharmacovigilance and project management initiatives at Accenture. I excel in Argus and LSMV database management and strategic planning. Demonstrated expertise in enhancing process efficiencies and training staff, underpinned by strong bilingual communication skills. Agile and adaptable staff leader with forward-thinking and industrious with diplomatic communication style focused on maximizing engagement and satisfaction.

Overview

10
10
years of professional experience

Work History

Associate Manager, Pharmacovigilance

Accenture
06.2021 - Current
  • Manage adverse event case processing teams, process and operations
  • Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner
  • Participated in development and continuous improvement of processes and workflow including SOPs
  • Participated in review, updating and execution of study/vendor specific documents, including PVA and SDEA
  • Lead Quality Governance meetings with clients where quality and compliance metrics are shared and discussed
  • Successfully managed multiple high-priority tasks simultaneously while maintaining strict deadlines ensuring optimal resource allocation
  • Led client meetings regularly to discuss progress updates, identify challenges or roadblocks, and provide solutions towards successful project completion
  • Safety Reconciliation handling of AE's between safety database and EDC
  • Kept records accurate, detailed and fully compliant with reporting requirements
  • Streamlined processes for increased efficiency and cost savings within the project using RPA
  • Enhanced team productivity by implementing efficient project management strategies
  • Experience in RPA (Robotic Process automation) of batch cases
  • Created employee schedules to align coverage with forecasted demands
  • Supervised day-to-day operations to meet performance, quality and service expectations
  • Helped with planning schedules and delegating assignments to meet coverage and service demands
  • Developed training materials, Quality review, conducted training presentations and on-the-job-training for pharmacovigilance staff
  • Worked on database migration transfer from AERS to Argus, Argus to LSMV database
  • Coordinated with the client & vendors during portfolio transitions including project plan creation, regular budget reviews, contingency planning and risk analysis
  • Lead an automation project in case allocation-based TA model that has increased efficiency and reduced people dependency
  • Performed Root cause analysis (RCA’s) of process deviations, regulatory and Business partner delays
  • Preparation of robust CAPA's on regulatory compliance and closure
  • Define and track KPI's (key performance indicators)
  • Successfully led multiple projects simultaneously while maintaining a focus on priorities, resource allocation, and overall strategic objectives
  • Automated RCA’s of Business partner delays by ~62%

Team Lead, Pharmacovigilance

Accenture
10.2017 - 05.2021
  • Creation and Implementation of Portfolio Quality Management framework for various therapeutic areas
  • Lead different therapeutic areas like Established Medicine, Respiratory, Retina/Ophthalmology and Oncology
  • Allocation of Safety Review cases to team members
  • Planned, organized and managed daily work to meet service level timelines and deliverables
  • Escalation of the issues or task outside the normal scope of work
  • Lead and act as the point of contact for client audits and inspections by regulatory authorities
  • Assign action items from these meetings to relevant SMEs and track them to completion
  • Ensured deviations and CAPAs are managed effectively and closed on time
  • Closely monitor and contribute to contract updates, subsequent changes required in the processes and monitor their completion
  • Lead the execution of all Audit/Inspection recommendations and findings in a timely manner and store objective evidence of completion of associated actions
  • Develop and lead the execution of deliverables in the Quality Management Plan for specific PV engagement in compliance with the contract for Accenture
  • Ensured client procedure documents (SOP’s and WI’s) are adhered to; by the team
  • Performed daily responsibilities in accordance with all applicable procedure documents, conventions and client policies
  • Evaluated team members’ adverse event case reports for performance improvement
  • Provided medical input on difficult adverse event cases
  • Served as point of contact between the Accenture and client teams
  • Participated and anchored weekly training and management calls
  • Facilitated therapeutics area group meetings (SPT, PGD, SGD’s) together with medical reviewers
  • Lead the Safety processing teams meeting between different vendors
  • Experience in handling Product guidance document, study guidance document meetings between client and vendor
  • Documented the MOM’s (Minutes of meetings) of the discussions and follow-up's for closure of actions
  • Assisted the team's production during spike in volumes whenever required and prepared back-up plan for any back-logs
  • Performed root cause analysis and corrective and preventive actions

Pharmacovigilance Analyst

Accenture
03.2016 - 09.2017
  • Maintained an awareness of global regulatory reporting obligations and organized workload to ensure compliance with internal and regulatory timelines for adverse event reporting
  • Drafted individual case summary reports and wrote concise case specific narratives as per company/product conventions
  • Drafted conventions for CAR-T cell therapy products and narrative conventions in coordination with PVL's.
  • Communicated with clients regarding case related queries and follow up
  • Attended project team meetings and client calls related to the project
  • Experience in different therapeutics areas like Established Medicine, Respiratory, Retina/Ophthalmology and Oncology
  • Requested and provided follow-ups on adverse events by preparing, sending out and tracking queries
  • Experienced in handling the ERP (Enterprise Resource Planning) system
  • As mentor, trained new team members on safety data processing and project related activities

Pharmacovigilance Specialist

Accenture
07.2014 - 02.2016
  • Hands-on expertise in end to end Case Processing in Pharmacovigilance database, ARGUS, ARISg, LSMV
  • Assessed labeling of serious adverse events originating from spontaneous, clinical sources with reference to IB, CCDS, SmPC, and USPI
  • Assisted in upgrading or downgrading of case, where applicable based on the medical assessment and seriousness criteria
  • Quality Check of Confidential which included review of source documents and ensuring that the case is accurate, correct and complete
  • Thorough understanding on SUSAR and compassionate use cases
  • Maintained a good working knowledge of the AE safety role of assigned drugs, reference Safety Information documents, data entry conventions and guidelines, clients' procedures and international drug safety regulations including:

Education

MASTER OF PHARMACY -

ANNAMALAI UNIVERSITY
Chidambaram
07-2013

Skills

  • Databases and Coding
  • Prioritization & Workflow management
  • Mentoring & Supervising
  • Compliance & Deviations
  • RCA & CAPA management
  • Client-vendor communications
  • Escalations
  • Relationship building
  • Project management
  • Time management
  • Presentation skills
  • Public speaking
  • Operations management
  • RPA/Robotic process automation

Languages

English
Bilingual or Proficient (C2)
Telugu
Advanced (C1)
Tamil
Intermediate (B1)

Hobbies

Reading & Home Schooling

Accomplishments

  • Achieved ~16k $ saving by introducing batch Macro for line-listing tasks. The new macro process is being rolled out to other projects to realize further savings.
  • Achieved automation in LP & KPI RCA's by developing MS Excel with ~62% accuracy and efficiency.

Timeline

Associate Manager, Pharmacovigilance

Accenture
06.2021 - Current

Team Lead, Pharmacovigilance

Accenture
10.2017 - 05.2021

Pharmacovigilance Analyst

Accenture
03.2016 - 09.2017

Pharmacovigilance Specialist

Accenture
07.2014 - 02.2016

MASTER OF PHARMACY -

ANNAMALAI UNIVERSITY

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