Project Manager
Resume:
Objective:
To join an organization, where I will be provided with the environment, to apply my knowledge and skills to bring better outcomes in the pharmaceutical industry.
Profile Summary:
Authoring of reports like PBRER, DSUR, PADER.
Experience in generating the Aggregate report Line listings and Summary tabulation.
Strong knowledge in MedDRA coding.
Expert in Excel formulas and functions.
Automated PBRER Sections 15.2, 16.3 and 16.4
workup, achieving 60% efficiency and 100%
quality of the sections.
Part of automation projects to improve the
process and deliverables.
Experience in handling of databases during MAH
spin-off or integrations. Responsible for
configuration/maintenance of tools used for line
listings and summary tabulations.
As a business owner, worked with Tech teams
and involved in Testing, Validation and UATs.
Audits, Deviation and CAPA Management.
Professional Experience:
IQVIA
Safety Aggregate reporting Manager
August-2021 to Present
Lead and manage the project to comply with the SOW and SLAs.
Oversees projects where Safety and Pharmacovigilance are the primary services.
Single point of contact between the team and the client for smooth functioning of the project.
Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan.
Works with Finance to ensure appropriate customer invoicing, where required.
Define and Create the Process flows and work instructions.
Train and mentor new team members as per requirements of the project.
Act as a management level liaison between Client and IQVIA Project team.
Provides sponsors with scheduled project updates and reports and acts as a point of escalation for sponsors
Record, maintain and track the metrics for both team members and project performance.
Review and evaluate aggregate report’s information to determine required action based on and following internal policies and procedures.
Provide guidance for aggregate report’s author and quality reviewer.
Recruit, select and train team members.
Participates in Audits and Inspections/Manages the deviation and CAPAs. **********@*******.***
Karthik Velusamy (M. Pharm)
Safety Aggregate reporting Manager
Project Manager with 11 years of experience in Aggregate report writing (PBRER, DSUR, PADER, PAER, ACO) and Individual Case Safety Reports (ICSR) processing. **********@*******.*** +91-978******* Bangalore, India https://www.linkedin.com/in/karthik-v- 0083b341/
2
IQVIA
Safety Aggregate reporting Specialist
December-2017 to July 2021
To Lead, author and finalize aggregate reports, including PBRERs, DSURs, PADERs, ACOs and six-monthly line listings; author responses to regulatory agency/PRAC inquiries, as required.
Conducts literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review.
Provide assistance in RMP/Signal detection and analysis activities, ensuring that safety signals are appropriately managed and tracked.
Ensure that narrative writing and benefit/risk assessment resources are appropriately trained on all approved project SOPs, guidelines and documents as required.
Plan, organize, and manage daily work to meet service level timelines and deliverables.
Work with the Aggregate Reporting lead to escalate issues or tasks outside the normal scope of work.
Provide word and PDF versions of the final signed documents to the client.
Participate in internal and external audits and inspections by clients and health authorities.
Ensure adequate and appropriate training and training documentation.
Cross check RMPs as required to draft aggregate reports.
Quality delivery through a rigorous metrics-based approach.
Ensure timeline are being met.
Perform any other drug safety related activities as assigned. IQVIA
Senior Drug Safety Associate (ICSR)
July 2016-Nov 2017
Prioritize and Assign cases to the Case Processors and track the cases till completion.
Process owner/SME for Non interventional Cases.
Ensure the Case Processing is completed for the Data Lock Points.
Actively participating in operational meetings to provide project status to the clients.
Prepare and provide the compliance reports to the management with Root Cause and CAPA for the SLA/KPIs not met.
End to end processing including registering, data entry, medical and drug coding, narrative writing, submission and follow up of various types of ICSR (Spontaneous, Clinical trial, Solicited, social media, and Literature) including special case types like Regulatory Authorities and Business partner cases according to standard operating procedures and regulatory guidelines.
Maintaining process documents to ensure team has access to all on-going process updates.
Mentoring new data entry personnel.
Review and provide inputs to the database migration plans and test the accuracy of migrations and provide the remediation plans.
Accenture Services Pvt Ltd
Pharmacovigilance Scientist
Jun 2013-Jun 2016
Processing and evaluation of Serious Adverse Events / Post Marketing Adverse Events /Non-serious events
(PSP cases, CT PMS cases, and Spontaneous cases) within agreed timeframes and to a high standard of accuracy in Argus database.
Ensure accurate and consistent coding of medical history, drugs and adverse event terms. Assess adverse event reports for seriousness, causality and expectedness.
Responsible for effective and efficient development of the safety management plan, including development of specific processes to assure consistency within the project.
Effectively maintains the safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process.
Preparation of study configuration requests in Argus database. 3
Educational Qualifications:
Title Institution Year Completed Marks
M.Pharm
(Pharmacology)
C.L.Baid Metha College of Pharmacy,
Chennai-97 2013 71%
B.Pharm Nandha College of Pharmacy, Erode-52 2010 61% Certifications and Courses:
Agile Project Management
Excel 2016: Advanced Formulas and Functions
Creating Dashboards in Excel
Data Analytics
Software Development Life Cycle (SDLC)
Quality Management for Operational Excellence
Technical Skills:
Expert: Excel formulas and functions, Formatting in word, Dashboards and Flow Charts
Expert: QlikView, OBIEE and Spotfire
Basic: SQL knowledge
Good Understanding of AI, Prompts, Data analysis and Generative Writing
Contact this candidate