Phebina Mary John Email & Phone Number

Toronto, Ontario, Canada

Toronto, Ontario, Canada

• Subject Matter Expert of safety data entry, case finalization and submissions.• Process safety data according to applicable regulations, guidelines, Standard Operating Procedures (SOPs) and project requirements.• Prepare Individual Case Safety Report for Customer Review within Safety database.• Assess safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, and oversight groups per legislation• Liaise with relevant stakeholders to facilitate expedited reporting.• Train and guide team members about new updates or process change

Mississauga, Ontario, Canada

● Perform Packaging Work Order review and establish Expiry Date for the finished pharmaceutical product. ● Uses TrackWise Quality Management System to complete CAPA action items; initiate and follow up with the actions required to close and complete Change Controls.● Review and revise SOPs: work closely with Compliance Department to ensure SOPs are reviewed and revised appropriately along with generating Knowledge Assessment Test questionnaire.● Prepares Work instructions (WIs), Quality Broadcast and other training documents in response to CAPA, comments/audits by clients and regulatory agencies.● Works closely with QA Reviewers team for the analysis of Right First Time report.● Member of the cross-functional team in conducting Risk Assessments like FMEA.● Prepare quality and productivity trend data from Key Performance Indicators for operations management.● Develops and maintains logbooks and other technical documents related to equipment and facility in the Packaging area.

Bengaluru Area, India

-Review and determine regulatory reporting requirements based on assessment of seriousness, causality and expectedness in accordance with regulatory guidelines and product labeling- Performing quality control review of the data entered in the safety database (SCEPTRE)- Initiating follow ups through setting due diligence letters and forms to health care providers, physicians and consumers- Verified clinical data integrity and accuracy.- Case processing related activities like review of consistency checks, reconciliation etc.- Training and mentoring peers in case processing methodologies and key skills in drug safety

Bengaluru Area, India

- Initial receipt and database searches as necessary, registry and triage incoming cases to determine seriousness for prioritization of daily workflow- Trained and mentored peers in case processing methodologies and key skills in drug safety- Conducted follow-up queries with clinical investigators regarding incomplete or unclear data

Bengaluru Area, India

- Entered appropriate data in the clinical database according to SOPs, selected appropriate event terms in MedDRA and wrote narratives summarizing the events.- Ensured accuracy of coding, that includes selecting appropriate event terms in MedDRA and worked closely with the coding department- Communicated closely with clinical investigators to ensure accuracy of data, that includes generating and resolving queries

Bengaluru Area, India

- Entered preliminary and follow-up information received via mail, telephone, and electrical source documents into global electronic adverse event database (SCEPTRE)- Coding relevant medical terminology, wrote descriptive narratives summarizing the events and generated advanced condition queries

Karnataka, India

- Provided clinical pharmacy services in General Medicine, Gynaecology and Obstetrics, Pediatrics, and Orthopaedics departments- Functioned as Drug Information Consultant for queries of the Health Care Professionals- Reported Adverse Drug Reactions and provided appropriate patient counselling

Karnataka, India

- Design and implement data collection form - Data collection, record data and source documentation and analysis of data- Prepare papers for presentation and publication in medical and scientific journals