Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
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Ziyaudin

Assistant Operations Manager In PV

Summary

Enthusiastic operations Manager with 13.8 years of overall experience in Pharmacovigilance and healthcare BPO. Majority of the career spent in pharmacovigilance, project management, people management, project stabilization and inspection readiness training. A postgraduate in Clinical Research and Regulatory Affairs with a track record of maintaining positive relationships with both customers and staff, dedicated to providing the highest quality pharmacovigilance deliverables to both internal and external customers.

Overview

16
16
years of professional experience
6
6
years of post-secondary education

Work History

Assistant Operations Manager

Accenture Services Pvt Ltd
Bengaluru
08.2017 - 01.2020
  • Supervise and manage the performance of book in, safety review and medical review teams.
  • Assisted with preparation and implementation of pharmacovigilance agreements and contracts.
  • ESR (SUSAR) project strategy planning, initiation, execution and stabilizing.
  • Increased productivity of Individual Case Safety Report (ICSR) handling by 20% while simultaneously stabilizing new projects.
  • Ensuring operational tools like failure mode effect analysis (FMEA), 5 whys, process chart, escalation matrix etc. are effectively used and upto date.
  • Resource planning, recruitment and onboarding for the Bangalore site.
  • Audit and Inspection readiness coach for the site.
  • CAPA preparation and effective implementation for book in/triage and safety review teams.
  • Developed and maintain operational guidelines for team leads and team members.
  • Taught employees how to collaborate on daily job tasks and achieve service targets.
  • Helped team members maintain business professionalism by coaching each on methods for delivering exceptional service to every customer.
  • Supervised operations team to support operational excellence and excellent customer service.
  • Oversaw adverse events case reporting and conducted follow-up if required.

Assistant Operations Manager

Accenture Services Pvt Ltd
Chennai
09.2011 - 09.2015
  • Supervise and manage the performance of 20 team members of Clinical, ESR and Spontaneous case processing team.
  • Ensured that all single case reports are adherent to FDA and EMEA guidelines and are submitted on time.
  • Prioritization of cases, regulatory aspects in pharmacovigilance.
  • Part of recruiting panel for selection of candidates.
  • Ensured that trainings are happening on time as per client requirement and health authorities’ regulation.
  • Played a role of trainer in order to train new joiners and also to update the team regarding regulatory change.
  • Handled staff requests, including requests for days off.
  • Coordinated with HR department to resolve staffing issues in a timely manner.
  • Tracked patient data by various search criteria, including patient age and condition for triaging purpose.
  • Hands on experience on Expedited Safety Reports (ESR).
  • Hands on experience in Triage/Case creation. Created all types of cases based on regulatory Requirements and their classifications.
  • Ensured that team is aware and update to date about ICH and GCP guidelines.

Drug Safety Associate

Accenture Services Pvt. Ltd
Chennai
03.2007 - 08.2011
  • Played role of back-up Team Lead for case processing and quality control (CP&QC) team with 40 FTEs.
  • Interim compliance Lead. (Independently handled Information security audit, documentation lead for Global Quality & Regulatory Compliance Audit and provided offshore support for FDA inspection).
  • Responsible for left out adverse event related data entry, MeDRA coding and narrative writing of single case then sending the updated/related documents or information to Medical Review Safety Physician.
  • Encode verbatim terms using MedDRA for patient history, product indication, death information screen, and event term information.
  • Processing the adverse event cases and analyzing the various serious and Non-serious adverse events pertaining to Spontaneous, Clinical Trials, Post Marketing Surveillance, Literature, etc.
  • Reviewed ancillary documentation to identify information for processing and electronic capture.
  • Communicated with internal or external contacts to resolve issues related to case processing.

Medical Transcriptionist

Medusind Solutions Pvt Ltd
Chennai
07.2006 - 03.2007
  • Attended training associated with role to improve skills and boost speed.
  • Followed all HIPAA rules and regulations regarding patient confidentiality.
  • Assisted in maintenance of medical charts and/or electronic medical record filing, Op Reports, test results and home care forms.
  • Recorded information using word processing, dictation and transcription software and equipment.
  • Preparing dictation segment, preparation of a variety of medical documents, i.e. discharge summaries, medical history and physical examination reports, operative reports, consultation reports, autopsy reports, diagnostic imaging studies, progress notes, and referral letters.

Quality Analyst (editor) Grade II

Insignia Pvt. Ltd
Chennai
12.2003 - 05.2006


  • Edition or quality reviewing of Junior Medical Transcriptionist (JMTs).
  • Quality check on all the transcription (transcribed files), average of 350 lines per day.
  • Giving feedback to the team members.
  • Responsible for work allocation based on the priority to the night shift and played a role of supervisor under the guidance of Managing director and Chairman.
  • Ensured Health Insurance Portability And Accountability Act (HIPAA) compliance.
  • Recognize, use appropriate medical abbreviations and terms.
  • Format, transcribe, and correctly prepare dictation in accordance with American association of medical transcription (AAMT) standards.

Education

Bachelor of Science - Microbiology

Madras University
Chennai
04.1999 - 03.2003

Master of Science - Clinical Research And Regulatory Affairs

Sikkim Manipal University
Gangtok,India.
03.2009 - 04.2011

Skills

Business Development

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Accomplishments

-Platinum certified BPO top talent person of Accenture (batch: 2013-2014).

-CZAR award winner for FY 13’s first Quarter for having zero net resignations in my team (Retention champion).

-One of the champions trophy award winner for exemplary contribution towards business operations and value creations leading to high performance (Team level award, lead by me and my counterpart).

-Oct-2010- Received monthly Numero Uno Award for effectively handling the cases without quality issues.

-Jun08, July08, Aug08-Quaterly Good Samaritan Award for displaying the essence of team spirit, playing critical role in the team’s success by stretching when required to share workload and use own expertise/knowledge to assist co-workers, and also for taking ownership.

- Mar2008-Received monthly Numero Uno Award for playing a role of effective backup for the supervisor, for excellent job in helping the team lead and handling cases.

- Dec2007- Quarterly superstar, certificate of appreciation for outstanding performance and lasting contributions.

- Received certificate of appreciation from Hi-Life for making community cerebrations a big success which was conducted across Accenture.

- Received other spot awards and deal star awards.

Timeline

Assistant Operations Manager

Accenture Services Pvt Ltd
08.2017 - 01.2020

Assistant Operations Manager

Accenture Services Pvt Ltd
09.2011 - 09.2015

Master of Science - Clinical Research And Regulatory Affairs

Sikkim Manipal University
03.2009 - 04.2011

Drug Safety Associate

Accenture Services Pvt. Ltd
03.2007 - 08.2011

Medical Transcriptionist

Medusind Solutions Pvt Ltd
07.2006 - 03.2007

Quality Analyst (editor) Grade II

Insignia Pvt. Ltd
12.2003 - 05.2006

Bachelor of Science - Microbiology

Madras University
04.1999 - 03.2003

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Ziyaudin Assistant Operations Manager In PV