Jijo R Mathew

• To check the order specs and related materials to complete order reports and run sheets

• Clean room Inspection of parts and update the data in the pasrtsmart.

• Create DMR report upon the damage found during the inspection of the parts

• Adhere to all safety precautions with machinery, tools, and devices, including use of relevant personal protective equipment (e.g. gown, cap, safety shoes, etc.)

• Ensures the quality of the parts produced by inspecting parts visually and through measuring devices, records measurement information and alerts appropriate personnel of any deviations from the customer specification or part print.
• Indicates the status of the part (Accept/Reject) according to proper procedure and specifications; packages parts per customer specification and places finished product in correct location.
• Records daily machine reports, including shot counts, scrap, cycle time, and production.
• Uses and understands statistical process control; monitors the quality of the product through Statistical Process Control (SPC), including the input of data into the computer.
• Maintains methods/procedures and all supporting documentation to meet the requirements of Quality Systems ISO9001:2000, ISO13485 and Environmental Management Systems ISO14001
• Adhere to all safety precautions with machinery, tools, and devices, including use of relevant personal protective equipment (e.g. gown, cap, safety shoes, etc.)
• Check's part counts by weighing them; sets scale and verifies scale accuracy.
• Ensures that the correct raw materials are being used at each moulding machine; ensures raw material is staged/ready for next shift

• As a senior individual contributor in Pharmacovigilance (PV), managed to lead safety signal detection, risk management, regulatory compliance, and data analysis efforts, while mentoring team members and driving continuous improvement to ensure patient safety and adherence to industry standards.
• Ensured accurate case processing and data quality by meticulously reviewing individual case safety reports (ICSRs) and supplementing missing information from source documents. Utilised MedDRA and WHO drug dictionaries to code patient histories, product information, and adverse events, enhancing report consistency and reliability.
• Coordinate with the medical writing team for accurate incorporation of the medical codings.
• Ensure adherence to ICH-GCP, regulatory guidelines, SOPs, and project specific guidelines.
• Handle any queries from both internal and external stakeholders also present it to team for training.
• Drafted written narrative summaries for each case, demonstrating strong narrative writing skills. Conducted validation checks, including e2b, and ensured cases are routed correctly for medical review.
• Maintained adherence to current FDA/ICH regulations, GMP, and client policies, ensuring operational excellence in pharmacovigilance activities. Led team with high standards, fostering a culture of compliance and quality.
• Develop, implement, and maintain compliance programs to ensure adherence to GVP, GxP, 21 CFR Part 11, and the EU AI Act.
• Consistently recognised as a top performer within the team, demonstrating exceptional accuracy and attention to detail.
• Mastered pharmacovigilance practices and regulatory guidelines, becoming a knowledgeable resource for the team and mentoring team.
• Manage change management and coordinate risk assessments and impact analyses for new systems, ensuring their suitability for regulated use.
• Conduct regular audits and assessments of internal processes and systems to ensure compliance with regulatory requirements.
• Investigate and resolve compliance issues and implement corrective and preventive actions.
• Displayed rapid learning capabilities, transitioning from novice to expert in pharmacovigilance operations and case management.
• Collaborated closely with clients, offering recommendations to enhance project outcomes.

• Managed case intake and documentation for adverse events, ensuring meticulous duplicate checks and registration.
• Performed triage and managed the Pharmacovigilance mailbox to ensure timely handling of safety-related correspondence.
• Analysed and processed individual case safety reports (ICSRs) with a focus on accuracy, consistency, and adherence to FDA/ICH regulations.
• Utilised medical dictionaries such as WHO-DD and MedDRA for precise coding of medical terms, enhancing report quality and regulatory compliance. Drafted clear and medically relevant safety narratives as part of pharmacovigilance reporting procedures.
• Conducted thorough follow-ups with sites to resolve queries and discrepancies, contributing to the integrity of safety data.
• Triage, tracks, and process safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
• Liaise with relevant stakeholders to facilitate expedited reporting. Maintains communication with investigative sites or marketed product reporters to obtain accurate data regarding safety events.
• Review clinical trial data and any other relevant documentation.
• Serve as point of contact for compliance-related issues with clients, addressing their concerns and ensuring their projects comply with all regulations also train staff on compliance, including GVP, GxP, and computer systems validation.
• Collaborated with cross-functional teams to gather necessary data and documents.
• Evaluates data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Represent Lifecycle Safety on projects and serve as primary point of contact within Lifecycle Safety for all internal and external customers.
• Contributes during client and internal audits and inspections for assigned projects.
• Prepares QC statements noting deficiencies with the analytical data set or notebooks.
• Conducted routine reconciliation of case reports, ensuring completeness and consistency of safety data.
• Monitor regulatory changes, update company policies, and promote continuous improvements.
• Ensure to meet quality, productivity and delivery standards per project requirements.