Summary
Overview
Work History
Education
Skills
Timeline
Manager

Abhishek Kumar Shandilya

Summary

A pharmacy graduate with around 10 years' experience in pharmacovigilance. I have good understanding of regulatory and pharmacovigilance practices. Talented Manager with expert team leadership, planning, and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach. As a manager, I am responsible for handling operations team, internal audits, hosting and managing external audits and facilitating accreditation and regulatory inspections. I also oversee vendor management, people management and operational excellence, ensuring compliance best practices and continuous improvement.

Overview

10
10
years of professional experience

Work History

Manager

Cognizant Technology Solutions
01.2024 - Current
  • Discussing all the operational parameters including monthly volume trends, SLA metrics, Quality Analysis, Reconciliation status, compliance metrics during joint operational monthly review with client.
  • Addressing weekly quality connects with client.
  • Managing a team size of 60 associates who are working on literature surveillance and handle (Triage, Data Entry, Quality review, medical review, and Case submission for solicited and unsolicited reports) in accordance with organization policies and applicable regulations.
  • Apprising performance and guiding professional development
  • Providing guidance and review of offerings-related activities, including scope of work, objectives, timelines and quality of deliverables
  • Track attendance on daily basis and maintaining acceptable adherence rate
  • Providing feedback to team on key performance indicators including quality and productivity
  • Actively involved in project billing
  • Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
  • Cross-trained existing employees to maximize team agility and performance.
  • Accomplished multiple tasks within established timeframes.
  • Onboarded new employees with training and new hire documentation.
  • Maintained professional, organized, and safe environment for employees and patrons.
  • Developed and maintained relationships with customers and vendors through account development.
  • Monitored and analyzed business performance to identify areas of improvement and make necessary adjustments.
  • Managed and motivated employees to be productive and engaged in work.
  • Communicated clearly with employees, and stakeholders to keep everyone on same page and working toward established business goals.

Team lead

Cognizant Technology Solutions
06.2020 - 12.2023
  • Workflow management which included allocation of cases for data entry, quality review and medical review on daily basis
  • Coached team members in techniques necessary to complete job tasks.
  • Tracking of cases for completion based on regulatory, SLA and internal timelines
  • Handled team of 15 members
  • Managed and ensured compliant safety reporting in accordance with international reporting regulations, and/or standard operating procedures
  • Responsible for providing mid-year and annual ratings and conducting appraisal for the tagged associates as per bell curve
  • Initiation of Process improvement programs for underperforming associates
  • Tracking of client mail boxes for queries and allocating it to designated associates on the floor as well as ensuring their completion within timelines
  • Responsible for providing feedback to associates and conducting performance meetings
  • Responsible for tracking training completion of associates who were tagged under me as per timeline
  • Participated in audit/inspection as required
  • Initiated process improvement Plan in term of quality to improve the project
  • Conducted interviews for the project.
  • Worked different stations to provide optimal coverage and meet production goals.
  • Evaluated employee skills and knowledge regularly, training, and mentoring individuals with lagging skills.
  • Trained new team members by relaying information on company procedures and safety requirements.

Sr. safety and PV specialist

Syneos Health
09.2017 - 04.2020
  • Assumes responsibilities of safety project leader for projects which require a team of Safety Specialists
  • Coordinates workload /workflow and status reviews
  • Manages systems for receipt and tracking adverse event (AE)/endpoint information
  • Assigns resources and timelines; reorganizes daily workload based on priority
  • Prepares Safety Management Plan
  • Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance; assists in the design and implementation of safety collection, processing, and reporting systems
  • Proactively communicates to management new issues and suggested solutions; reports availability to take on new assignments
  • Processes Adverse Events (AEs)/Endpoints according to Standard Operating Procedures (SOP) and project specific safety plans
  • Participates in generation of reports to the sponsor and regulatory authorities, ensures timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements
  • Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety database
  • Assists training of Investigators and other departments on AE reporting
  • Delivers presentations regarding safety and pharmacovigilance to internal and external customers.
  • Interpreted clients' needs and introduced services to fit specific requirements.
  • Followed all company policies and procedures to deliver quality work.

Sr. pharmacovigilance associate

APCER Life science
11.2014 - 09.2017
  • Review and process adverse events reported by Investigators and spontaneously on ARGUS database
  • Generates concise, accurate and well-written case narratives
  • Processing Spontaneous & Solicited reports, E2B submitted reports, Summary reports
  • Performs consistent coding of diseases, adverse events, and medication according to the project-specific coding conventions
  • Effectively use of safety database and corresponding entry guidelines, including accurate entry of data and assurance of quality of data through quality control process.
  • Oversaw adverse events case reporting and conducted follow-up.
  • Responded to requests from regulatory agencies and notified to share information.

Pharmacovigilance Officer

WIPRO
01.2014 - 11.2014
  • Received and tracked information regarding potential adverse events submitted by all reporters including consumers, healthcare professionals, co-manufacturers, call centers, medical information centers, quality assurance and other company representatives accurately with in defined reporting timelines
  • Processing of adverse event reports from solicited, spontaneous and regulatory authority reports
  • Proficiency in preparing AEM Forms and Individual Case Safety Report (ICSR)
  • Assessing adverse events as serious and non-serious
  • Adverse event case entry and case processing, coding and narrative writing of serious and non-serious cases
  • Work on ARGUS
  • Team player with good communication and inter personal skills
  • Excellent oral and written communication skills.

Education

B.Pharma -

Srinivas college of pharmacy, RGUHS Karnataka (PCI Approved)

12th -

Holy Convent School (CBSE Delhi)

10th - undefined

Convent of Gagan Bharti (CBSE Delhi)

Skills

Business Development

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Timeline

Manager

Cognizant Technology Solutions
01.2024 - Current

Team lead

Cognizant Technology Solutions
06.2020 - 12.2023

Sr. safety and PV specialist

Syneos Health
09.2017 - 04.2020

Sr. pharmacovigilance associate

APCER Life science
11.2014 - 09.2017

Pharmacovigilance Officer

WIPRO
01.2014 - 11.2014

B.Pharma -

Srinivas college of pharmacy, RGUHS Karnataka (PCI Approved)

12th -

Holy Convent School (CBSE Delhi)

10th - undefined

Convent of Gagan Bharti (CBSE Delhi)

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Abhishek Kumar Shandilya