Mahammad Farook Shaik

Job Responsibilities at IQVIA:

Key highlights of work experience:

• Submission of PM cases to USFDA via Argus DATA base.

• Submission of PADER's within the Argus DATA base (Bulk reporting).

• CT cases submission via e-mails and Portal to respective Regulatory Authorities.

• Submission of PSUR (Bimonthly, 6 monthly line listing) and PBRER.

• Investigator Alert Letters submission via e-mails, ISG DrugDev DATA base.

Other highlights:

• Triage, review and process data from various sources on time, and meet quality standards,

generating queries pertinent to the case, performing quality control, assisting with reconciliation

and ensuring reports are sent to the customer within assigned deadlines.

• Preparation of material for submission of primary review.

• Assess Lifecycle Safety data for report ability to relevant authorities, track reportable cases and

report to regulatory authorities, ethics committees, institutional review boards, investigators,

oversight groups per legislation, within timelines and in a format compatible to requirement.

• Liaise with local IQVIA offices to facilitate expedited reporting.

• Process Lifecycle Safety data according to applicable regulations, guidelines, Standard Operating

Procedures (SOPs) and project requirements.

• Assist operations team with tasks, provide for back-up to the operations team and assist in implementation of new processes.

• Contribute under guidance of senior staff to individual deliverables in the field of Safety Publishing or other service lines as appropriate.

• Liaise with different functional team members, e.g., project management, clinical, data

Management; health care professionals e.g., investigators, medical monitors, site coordinators

and designee to address project related issues.

• Attend project team meetings and provide feedback to operations manager on any

challenges/issues or successes.

• Perform operational and collaborative LSM task as directed by Lifecycle Safety Infrastructure.

• Ensure compliance to IQVIA high quality standards.

• Collaborating with SO team to help achieve operational departmental goals i.e., understands

metrics appropriate to quality document management and assist in the achievement of

productivity utilization and realization metrics.

• Performing other duties as assigned

Job Responsibilities at Bioclinica:

➢ Case processing (involves all ICSR'S, Solicited PSP serious and non-serious, Spontaneous serious and non-serious, Logical deletion cases).

➢ Acknowledge the safety information to the sender.

➢ Enter all relevant data into the safety database based on the information available in the source documents.

➢ Prepare a case narrative for each case, which reflects the safety data.

➢ Add any follow-up information to the case narrative initially entered into the Global Safety Database.

➢ Perform validation of the data for each case and make corrections (if any) as needed.

➢ Send queries and review responses to queries when received and update the safety database as required.

➢ Ensure compliance to client SOPs, conventions and guidelines for all activities performed.

➢ Identifying duplicate cases in database and merging those reports within database.

As a Quality Reviewer:

Checking the quality of case processor and providing feedback regarding errors and assessment of the complete safety repot.

As Medical Coder:
Responsible for coding all medical history, events, drugs/procedures/indications and laboratory tests according to the appropriate dictionary (For e.g. Med DRA, Company Product Dictionary, WHO-DD).

As Case Intake Member (Triage):
Responsible for case intake, duplicate check and registration, maintain log of source documents and other communications.

As Case Processor:

➢ Responsibilities for case processing as per related SOP work document, Sponsor reference document etc.

➢ Responsible for case processing of adverse events of ICSR.

➢ Responsible to enter the data as per the source documents which is relevant to identifiable patient, Reporter information, Suspect adverse event and Suspect drug.

➢ Ensure scientific rigor through accurate, complete and consistent data entry of adverse event

reports from source documents with emphasis on timeliness and quality.

➢ Responsibilities to maintain quality and timeline in processing.

➢ Responsible to data security with regards to prohibited health information.

➢ To identify issue and queries if any during case processing to concern with TL, PM to take necessary and corrective action and same shall be tracked and documented for Audit Purpose.

As Narrative writer:

Responsible for writing medically relevant safety narrative of cases and checking the completeness and accuracy of the data entered in the various fields.

Other Responsibilities:

• Assigning the cases with in the Arisg data base and through e-mail for case processing team.

• Assigning the cases with in the ICSR Mailbox for Triage activity.

• Refuting in post approval quality check (PAQC), weekly basis.

• Conducting refresher trainings for Triage and case processing Teams.

• Following up with sites regarding outstanding queries.

• Closure and deletion of cases.

• Perform any other drug safety related activities as assigned.

• Perform literature review activities when trained and assigned Computer.

• Proficiency- MS Office, Internet applications.

• Ability to mentor and handle given responsibilities with understandings.

• Teamwork, Time management, good documentation and listening skills.

• Good analytical skills.