Summary
Overview
Work History
Education
Skills
Certification
Languages
Timeline
Generic
MOHAMMED RAFFIK HAJA SHERIEF

MOHAMMED RAFFIK HAJA SHERIEF

Chennai

Summary

Dynamic Pharmacovigilance Project Lead at ICON Clinical Research with expertise in Argus Safety Database and project management. Proven track record in enhancing project profitability and ensuring compliance with global regulations. Adept at client relationship management and team leadership, driving continuous improvement initiatives to exceed service level agreements.

Overview

26
26
years of professional experience
1
1
Certification

Work History

PHARMACOVIGILANCE PROJECT LEAD

ICON CLINICAL RESEARCH
09.2013 - 04.2025
  • Responsible for performing oversight and/or processing for all types of safety events (including safety database entry, narrative preparation, and quality review functions), and other medically-related project information; serving as pharmacovigilance (PV) lead for projects providing project management/project management support as designated; serving as support to management in all aspects of departmental activities, including coordination of extradepartmental tasks as needed; serving as technical expert with regard to all aspects of safety monitoring, per global regulations (FDA, ICH, EMA); ensuring all Sponsor, and regulatory timeframes are met for the processing and reporting of safety information; and assisting in ensuring the completion of all departmental project activities accurately in accordance with Company standards, regulatory requirements, and contractual obligations to Sponsors.
  • Project oversight: Maintains oversight of project set-up, maintenance, and close-out including training, project documentation updates, filing, metrics (including collation and timelineness), PV deliverables, contracts/change orders, and quality (including retrospective QC for applicable projects).
  • Reviews project profitability on at least a quarterly basis with the Project Director. Where actions are required implements a plan to address low profitability (e.g. initiate change order, process improvements, ensure all items invoiced).
  • Deviation and CAPA tracking and escalation: Ensure project and process deviations related to PV activities are documented on the project deviation log, brought to the attention of the project director, and closed out with applicable actions in a suitable amount of time (depending on each deviation). Ensures preparation for upcoming audits/inspections is coordinated. Where there are audit/inspection findings ensures the RCA and corrective/preventative actions are documented within the timelines.

QUALITY REVIEW TEAM LEAD /SME

ACCENTURE SERVICES PVT LTD
09.2008 - 08.2011
  • Responsible for allocating cases to the team members and clarify doubts to them. Help the team leaders in plan, organize, and manage daily work to meet service level timelines and deliverables.
  • Review all forms and documents pertaining to a case for errors, missing information, legibility.
  • Responsible for escalating the issues or tasks outside the normal scope of work.
  • Ensure all guidelines and SOPs are followed effectively by all the team members.
  • Clarifying doubts with respect to process on floor Updating team on all the recent updates reported by the client.
  • Collating questions for training call. Participate/anchor the training call and ensure the entire team gets updated of the proceedings.
  • Review feedback received via weekly score cards Coach new team members for certification.
  • Keep supervisors updated on individual team members requirement for additional training (whenever required).
  • Ensure the trainees are brought into live phase within specified timelines.
  • Ensure all process related updates are done accordingly to the team.
  • Identify, support, and implement continuous improvement activities.
  • Build relationship and credibility with the client.
  • Plan and organize work so that all the applicable and agreed SLAs are realized.
  • Ensure compliance with Business policy and contractual requirements of company.
  • Ensure a continuous engagement with the client for all mutual activities and trainings.
  • Understand and abide by timelines without compromising on quality.
  • Assist in the evaluation of current procedures to help improve speed and accuracy.
  • Coordinate effectively with mobilization to ensure smooth transition, effective knowledge transfer of all processes so as to ensure optimum operations.
  • Demonstrate the ability to work as a part of the team and also effectively lead the team.
  • Seek advice and escalate issues when facing tasks or problems outside the normal scope of the job.
  • Adaptable to learn new processes, concepts and skills.
  • Leverage experience to assist colleagues with medical queries.
  • Coordinate with the internal services of company in coordination with the relevant single point of contacts (SPOCs) for any team related requirements in relation to the periodic HR appraisal process, departmental budgets, Recognition and Reward(R&R) initiatives, technology issues, Facilities and Services (F&S) requirements, team bonding activities and any other related activities.
  • To ensure in coordination with the onshore and service management teams within the company, that an effective SLA tracking procedure is in place and is being implemented on a day-to-day basis in a robust manner.
  • To ensure effective coordination for a continuous upgradation with all the stakeholders and the team members.

MEDICAL EDITOR

SPI TECHNOLOGIES PVT LTD
12.2007 - 09.2008
  • Responsible for allocating cases to the team members and clarify doubts to them. Help the team leaders in plan, organize, and manage daily work to meet service level timelines and deliverables.
  • Review all forms and documents pertaining to a case for errors, missing information, legibility.
  • Responsible for escalating the issues or tasks outside the normal scope of work.
  • Ensure all guidelines and SOPs are followed effectively by all the team members.
  • Clarifying doubts with respect to process on floor Updating team on all the recent updates reported by the client.
  • Collating questions for training call. Participate/anchor the training call and ensure the entire team gets updated of the proceedings.
  • Review feedback received via weekly score cards Coach new team members for certification.
  • Keep supervisors updated on individual team members requirement for additional training (whenever required).
  • Ensure the trainees are brought into live phase within specified timelines.
  • Ensure all process related updates are done accordingly to the team.
  • Identify, support, and implement continuous improvement activities.
  • Build relationship and credibility with the client.
  • Plan and organize work so that all the applicable and agreed SLAs are realized.
  • Ensure compliance with Business policy and contractual requirements of company.
  • Ensure a continuous engagement with the client for all mutual activities and trainings.
  • Understand and abide by timelines without compromising on quality.
  • Assist in the evaluation of current procedures to help improve speed and accuracy.
  • Coordinate effectively with mobilization to ensure smooth transition, effective knowledge transfer of all processes so as to ensure optimum operations.
  • Demonstrate the ability to work as a part of the team and also effectively lead the team.
  • Seek advice and escalate issues when facing tasks or problems outside the normal scope of the job.
  • Adaptable to learn new processes, concepts and skills.
  • Leverage experience to assist colleagues with medical queries.
  • Coordinate with the internal services of company in coordination with the relevant single point of contacts (SPOCs) for any team related requirements in relation to the periodic HR appraisal process, departmental budgets, Recognition and Reward(R&R) initiatives, technology issues, Facilities and Services (F&S) requirements, team bonding activities and any other related activities.
  • To ensure in coordination with the onshore and service management teams within the company, that an effective SLA tracking procedure is in place and is being implemented on a day-to-day basis in a robust manner.
  • To ensure effective coordination for a continuous upgradation with all the stakeholders and the team members.

SENIOR MEDICAL TRANSCRIPTIONIST

A.M. TRANSCRIBE PVT LTD
06.2006 - 11.2007
  • Responsible for editing the process of converting voice recorded reports as dictated by physicians and/or other healthcare professionals into text format done by the Medical Transcriptionist.
  • Distinguish between homonyms, and recognize inconsistencies and mistakes in medical terms, referring to dictionaries, drug references, and other sources on anatomy, physiology, and medicine.
  • Review and edit transcribed reports or dictated material for spelling, grammar, clarity, consistency, and proper medical terminology.
  • Set up and maintain medical files and databases, including records such as x-ray, lab, and procedure reports, medical histories, diagnostic workups, admission and discharge summaries, and clinical resumes.

SENIOR MEDICAL TRANSCRIPTIONIST

ISAN MEDISCRIBE PVT LTD
01.2002 - 05.2006
  • Responsible for editing the process of converting voice recorded reports as dictated by physicians and/or other healthcare professionals into text format done by the Medical Transcriptionist.
  • Distinguish between homonyms, and recognize inconsistencies and mistakes in medical terms, referring to dictionaries, drug references, and other sources on anatomy, physiology, and medicine.
  • Review and edit transcribed reports or dictated material for spelling, grammar, clarity, consistency, and proper medical terminology.
  • Set up and maintain medical files and databases, including records such as x-ray, lab, and procedure reports, medical histories, diagnostic workups, admission and discharge summaries, and clinical resumes.

MEDICAL TRANSCRIPTIONIST

PRIMETECH INFO SYSTEMS
02.2000 - 12.2002
  • Distinguish between homonyms, and recognize inconsistencies and mistakes in medical terms, referring to dictionaries, drug references, and other sources on anatomy, physiology, and medicine.
  • Review and edit transcribed reports or dictated material for spelling, grammar, clarity, consistency, and proper medical terminology.
  • Set up and maintain medical files and databases, including records such as x-ray, lab, and procedure reports, medical histories, diagnostic workups, admission and discharge summaries, and clinical resumes.

MEDICAL TRANSCRIPTIONIST

TULYSYAN TECHNOLOGIES PVT LTD
06.1999 - 01.2000
  • Distinguish between homonyms, and recognize inconsistencies and mistakes in medical terms, referring to dictionaries, drug references, and other sources on anatomy, physiology, and medicine.
  • Review and edit transcribed reports or dictated material for spelling, grammar, clarity, consistency, and proper medical terminology.
  • Set up and maintain medical files and databases, including records such as x-ray, lab, and procedure reports, medical histories, diagnostic workups, admission and discharge summaries, and clinical resumes.

Education

Bachelor of Science - CHEMISTRY

THE NEW COLLEGE
CHENNAI, INDIA
04-1999

Skills

  • C
  • C
  • Java
  • MS Office
  • Oracle Clinical EDC System
  • Inform EDC System
  • DATATRAK EDC System
  • Argus Safety Database
  • Clintrace Safety Database
  • Project management
  • Project coordination
  • Client relationship management
  • Team leadership
  • Project documentation
  • Innovation skills
  • Cost control

Certification

  • MedDRA coding
  • End User Training in Clintrace Safety Database
  • Argus End User Training Certificate (Webex training) from Oracle

Languages

English
First Language

Timeline

PHARMACOVIGILANCE PROJECT LEAD

ICON CLINICAL RESEARCH
09.2013 - 04.2025

QUALITY REVIEW TEAM LEAD /SME

ACCENTURE SERVICES PVT LTD
09.2008 - 08.2011

MEDICAL EDITOR

SPI TECHNOLOGIES PVT LTD
12.2007 - 09.2008

SENIOR MEDICAL TRANSCRIPTIONIST

A.M. TRANSCRIBE PVT LTD
06.2006 - 11.2007

SENIOR MEDICAL TRANSCRIPTIONIST

ISAN MEDISCRIBE PVT LTD
01.2002 - 05.2006

MEDICAL TRANSCRIPTIONIST

PRIMETECH INFO SYSTEMS
02.2000 - 12.2002

MEDICAL TRANSCRIPTIONIST

TULYSYAN TECHNOLOGIES PVT LTD
06.1999 - 01.2000

Bachelor of Science - CHEMISTRY

THE NEW COLLEGE
MOHAMMED RAFFIK HAJA SHERIEF