Pharmacovigilance Manager

The Pharmacovigilance Manager is accountable for ensuring the safety and quality of Getz Pharma Phils., products by overseeing the collection, assessment, and reporting of adverse events in compliance with local and international regulatory requirements. This role ensures that all pharmacovigilance activities are performed in accordance with applicable regulations, maintaining patient safety and product integrity. The Pharmacovigilance Manager is responsible for managing risk assessments, ensuring the timely submission of safety reports, and collaborating with cross-functional teams to mitigate risks and enhance the safety profile of Getz Pharma Phils., products.

Responsibilities

Pharmacovigilance

Adverse Event Reporting

• Responsible for immediately reporting all adverse related to our products, as per local regulation.
• For each case, prepare assessment report and conduct a casualty assessment using tools such as the Naranjo Scale and provide a detailed report to head office at time of report
• Ensure the reports are accurate, complete and timely submitted to the FDA- Philippines.

Database Maintenance

• Maintain a comprehensive database of all reported adverse events and continuously monitor for any trends or patters and send to head office at time of report.
• Regular update the database and ensure that it is fully compliant with the local regulatory.

Local Regulatory Compliance on Pharmacovigilance

• Ensure compliance with the latest regulatory changes in the Philippines related to pharmacovigilance regulations and guidelines (e.g., FDA, etc.).

Preparation of PSUR (Periodic Safety Update Report)

• Prepare and submit periodic safety update reports (PSURs), risk management plans (RMPs), and other safety reports to regulatory authorities.
• Ensure PSURs are submitted within the required timelines, this include collecting relevant safety data, assessing it, and providing recommendations to ensure patient safety.

Risk Management Plan

• Prepare and update RMP as per regulatory requirements in the Philippines
• Assess the risk-benefit profile of products and contribute to risk management plans.
• Ensure identification of risks, risk minimization strategies and ensuring that the RMPs are in line with the FDA-Philippines guidelines.

Directly communicates with the Main Qualified Person Responsible for Pharmacovigilance in Pakistan

• Report all adverse event assessment and cases directly to QPPV (Head office)
• Provide an assessment report, include findings and Naranjo Scale score, before closing the case and provide feedback.
• Collaborate with other departments such as regulatory affairs, clinical development, and medical affairs to ensure safety issues are addressed and communicated appropriately.

Collaboration and Training

• Collaborate with other departments such as regulatory affairs to ensure safety issues are addressed and communicated appropriately.
• Conduct training sessions as needed for staff and healthcare professional’s on adverse event reporting, pharmacovigilance best practices and regulatory compliance.
• Ensure pharmacovigilance related queries or investigations are actioned.

Quality Assurance

Management System

• Works with the Quality Assurance Supervisor and the Quality Director, also the Deputy Management Representative (MR) in the design, development, implementation and continual improvement of the company’s management system.
• Handless the over-all Validation & Qualification Program of Getz Healthcare.
• Manage & analysis of Quality data for the organization.
• Supervise and direct quality assurance associates who are responsible for ensuring the effective implementation of Quality Management System on their respective sites and other quality-related policies in order to meet product quality standard.
• Conducts mentoring, training and performance evaluation to Quality Associates to ensure good performance.
• Ensures that all issues and concerns regarding Quality are immediately acted upon and/or reported to the Quality Assurance Director or to the concerned departments.
• Assists in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.
• Ensure compliance to Deviation Management and Change Management Procedures.
• Conducts training on quality-related procedures and standards such as GMP, GDPMDD, ISO 9001 and RQA Guidelines.
• Act as a Lead in EMS Programs.

Quality Audit

• Works with the Systems and Compliance Officer and Internal Quality Audit Team in conducting routing operational audit to ISO 9001:2015, good distribution and storage practices, and good manufacturing practices compliance.
• Attends the internal, client or external audits, regulatory visits/inspections/audits, and audits of the third party service providers. Raise Corrective and Preventive Action (CAPA) Report on the identified nonconformities.
• In coordination with the various site Managers, may lead the Client audits and other external audits in the sites as the need arises.
• Coordinate and follow through with the Process Owners for the submission of corrective actions on non-conformity reports or deviations. Report to Management on the performance of the Quality Management System as well as the non-conformities observed.
• Assists in complying with audits/routine inspection from Regulatory Bodies (FDA/PDEA) and other government agencies.
• Act as internal auditor in the conduct of the Internal Quality Audit.
• Assist in preparing audit program, plan and conduct internal audits / inspections in the specified branches to check on operational departments’ compliance to established procedures, ISO 9001, GSDP, GDPMDD, cGMP, regulatory and other international standards requirements as well preparation for Clients, Regulatory or other external audits

Quality Assurance

• Ensures compliance to client, regulatory requirements, international standards and procedures applicable to the Distribution Center.
• Spearheads quality programs and initiatives for continual improvements by driving improvements activities or changes in processes or systems through coordination with cross functional project teams.
• Make proactive recommendations to the Quality Assurance Director to improve quality and work efficiency.
• Ensures recording and timely reporting of periodic Management Reports such as Quality KPIs.
• Collates data and does comparative analysis of performance to serve as point of reference for process improvements.
• Signs and approves documents within level of authority.

Administration

• Prepares and provides the reportorial requirements of the company and principals as requested.
• Recommends to manage the necessary interventions, policies, and procedures that will make the delivery of the function’s objectives effective and efficient.
• Perform other job functions as directed by the Quality Director from time to time or as may be necessary in support of company objectives.

Qualifications

• A minimum of a Bachelor’s Degree in Pharmacy, Medicine Life Sciences or related field.
• A minimum of 3-5 years of experience in Pharmacovigilance or Drug Safety and Quality Assurance and Management System with demonstrated experience in Regulatory Compliance, Safety Reporting and Risk Management.
• Qualified Pharmacovigilance Certified (where applicable by regulatory bodies) or equivalent experience.
• Experience with Clinical Trial Safety Data
• Familiarity with Signal Detection and Risk Management Activities

The Pharmacovigilance Manager is accountable for ensuring the safety and quality of Getz Pharma Phils., products by overseeing the collection, assessment, and reporting of adverse events in compliance with local and international regulatory requirements. This role ensures that all pharmacovigilance activities are performed in accordance with applicable regulations, maintaining patient safety and product integrity. The Pharmacovigilance Manager is responsible for managing risk assessments, ensuring the timely submission of safety reports, and collaborating with cross-functional teams to mitigate risks and enhance the safety profile of Getz Pharma Phils., products.

Responsibilities

Pharmacovigilance

Adverse Event Reporting

• Responsible for immediately reporting all adverse related to our products, as per local regulation.
• For each case, prepare assessment report and conduct a casualty assessment using tools such as the Naranjo Scale and provide a detailed report to head office at time of report
• Ensure the reports are accurate, complete and timely submitted to the FDA- Philippines.

Database Maintenance

• Maintain a comprehensive database of all reported adverse events and continuously monitor for any trends or patters and send to head office at time of report.
• Regular update the database and ensure that it is fully compliant with the local regulatory.

Local Regulatory Compliance on Pharmacovigilance

• Ensure compliance with the latest regulatory changes in the Philippines related to pharmacovigilance regulations and guidelines (e.g., FDA, etc.).

Preparation of PSUR (Periodic Safety Update Report)

• Prepare and submit periodic safety update reports (PSURs), risk management plans (RMPs), and other safety reports to regulatory authorities.
• Ensure PSURs are submitted within the required timelines, this include collecting relevant safety data, assessing it, and providing recommendations to ensure patient safety.

Risk Management Plan

• Prepare and update RMP as per regulatory requirements in the Philippines
• Assess the risk-benefit profile of products and contribute to risk management plans.
• Ensure identification of risks, risk minimization strategies and ensuring that the RMPs are in line with the FDA-Philippines guidelines.

Directly communicates with the Main Qualified Person Responsible for Pharmacovigilance in Pakistan

• Report all adverse event assessment and cases directly to QPPV (Head office)
• Provide an assessment report, include findings and Naranjo Scale score, before closing the case and provide feedback.
• Collaborate with other departments such as regulatory affairs, clinical development, and medical affairs to ensure safety issues are addressed and communicated appropriately.

Collaboration and Training

• Collaborate with other departments such as regulatory affairs to ensure safety issues are addressed and communicated appropriately.
• Conduct training sessions as needed for staff and healthcare professional’s on adverse event reporting, pharmacovigilance best practices and regulatory compliance.
• Ensure pharmacovigilance related queries or investigations are actioned.

Quality Assurance

Management System

• Works with the Quality Assurance Supervisor and the Quality Director, also the Deputy Management Representative (MR) in the design, development, implementation and continual improvement of the company’s management system.
• Handless the over-all Validation & Qualification Program of Getz Healthcare.
• Manage & analysis of Quality data for the organization.
• Supervise and direct quality assurance associates who are responsible for ensuring the effective implementation of Quality Management System on their respective sites and other quality-related policies in order to meet product quality standard.
• Conducts mentoring, training and performance evaluation to Quality Associates to ensure good performance.
• Ensures that all issues and concerns regarding Quality are immediately acted upon and/or reported to the Quality Assurance Director or to the concerned departments.
• Assists in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.
• Ensure compliance to Deviation Management and Change Management Procedures.
• Conducts training on quality-related procedures and standards such as GMP, GDPMDD, ISO 9001 and RQA Guidelines.
• Act as a Lead in EMS Programs.

Quality Audit

• Works with the Systems and Compliance Officer and Internal Quality Audit Team in conducting routing operational audit to ISO 9001:2015, good distribution and storage practices, and good manufacturing practices compliance.
• Attends the internal, client or external audits, regulatory visits/inspections/audits, and audits of the third party service providers. Raise Corrective and Preventive Action (CAPA) Report on the identified nonconformities.
• In coordination with the various site Managers, may lead the Client audits and other external audits in the sites as the need arises.
• Coordinate and follow through with the Process Owners for the submission of corrective actions on non-conformity reports or deviations. Report to Management on the performance of the Quality Management System as well as the non-conformities observed.
• Assists in complying with audits/routine inspection from Regulatory Bodies (FDA/PDEA) and other government agencies.
• Act as internal auditor in the conduct of the Internal Quality Audit.
• Assist in preparing audit program, plan and conduct internal audits / inspections in the specified branches to check on operational departments’ compliance to established procedures, ISO 9001, GSDP, GDPMDD, cGMP, regulatory and other international standards requirements as well preparation for Clients, Regulatory or other external audits

Quality Assurance

• Ensures compliance to client, regulatory requirements, international standards and procedures applicable to the Distribution Center.
• Spearheads quality programs and initiatives for continual improvements by driving improvements activities or changes in processes or systems through coordination with cross functional project teams.
• Make proactive recommendations to the Quality Assurance Director to improve quality and work efficiency.
• Ensures recording and timely reporting of periodic Management Reports such as Quality KPIs.
• Collates data and does comparative analysis of performance to serve as point of reference for process improvements.
• Signs and approves documents within level of authority.

Administration

• Prepares and provides the reportorial requirements of the company and principals as requested.
• Recommends to manage the necessary interventions, policies, and procedures that will make the delivery of the function’s objectives effective and efficient.
• Perform other job functions as directed by the Quality Director from time to time or as may be necessary in support of company objectives.

Qualifications

• A minimum of a Bachelor’s Degree in Pharmacy, Medicine Life Sciences or related field.
• A minimum of 3-5 years of experience in Pharmacovigilance or Drug Safety and Quality Assurance and Management System with demonstrated experience in Regulatory Compliance, Safety Reporting and Risk Management.
• Qualified Pharmacovigilance Certified (where applicable by regulatory bodies) or equivalent experience.
• Experience with Clinical Trial Safety Data
• Familiarity with Signal Detection and Risk Management Activities