Senior Process Associate, Junior Data Analyst, Senior Process Associate

Achievements/Tasks
Implemented consistent, efficient and quality processes to meet timeline and deliverable
according to requirements and standard operating procedures.

Ensured compliance of operations with governing regulatory requirements.
Created, maintain and assume accountability for a culture of high customer services.
Executed drug safety data management processes- a combination of case entry, medical coding,
narrative writing, peer review, case follow up, report preparation and submission to regulatory
authorities.
Assumed responsibility for quality of data processed.

Achievements/Tasks
Collaborated with quality and other relevant stakeholders for individual complaint case
processing and other relevant safety activities including complaint processing and prioritization,
medical coding and trending.
Reviewed investigations of all safety incidents or concerns and assists with completion of
corrective action plans.
Reviewed, entering and verifying follow-up and ancilliary information for cases submitted for
medical review and risk assessment.
Analyzed data relating to safety and health issues, prioritizes situations, and drives the process
of correcting or improving areas of concern.

Represented Global Medical Safety in relevant quality assurance and risk management
initiatives including complaint prioritization, product risk and post-market surveillance reviews.
Reviewed project performance metrics (including quality parameters, monthly budget reports,
and changes in scope).