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.

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.

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.

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