New Jersey Staffing
Manager, Pharmacovigilance Quality Assurance
New Jersey Staffing, Bound Brook, New Jersey, us, 08805
Pharmacovigilance Quality Assurance Manager
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, PEOPLE Companies That Care, Best Workplaces for Women, Best Workplaces for Millennials, and Best Medium Workplaces lists. Reporting to the Sr Director, Quality Assurance - Pharmacovigilance, the Manager of Pharmacovigilance Quality Assurance serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance (DSPV), Medical Information (MI), and Clinical Departments. The incumbent will provide support and promote collaboration with cross functional internal and external teams to ensure all systems, processes, and outcomes comply with applicable global standards, regulations, and guidelines. Responsibilities
* Support the evaluation and acceptability of vendors, partners, and other external organizations related to Pharmacovigilance (PV) activities such as Patient Support Programs, Specialty Pharmacies, and Market Research, for qualification. * Conduct and/or assist with the completion and evaluation of supplier pre-qualification surveys. * Creation and maintenance of vendor organization records related to PV activities in the QMS system. * Conduct internal and external risk assessments of PV process systems, vendors, partners, and other external organizations related to PV activities. * Provide input into the annual audit schedule for internal and external audits related to PV activities based on the output of the risk assessments. * Lead or co-lead internal and external pharmacovigilance audits (such as PV process systems, Patient Support Programs, Market Research, Specialty Pharmacies) including planning, execution, and reporting. * Communicates audit outcomes to collaborators and writes the audit report. * Assesses audit responses and ensures proposed corrective action preventative actions (CAPA) received by auditee(s) are adequate. * Provides oversight and monitoring to ensure timely closure of all CAPAs. * Review and approve internal and external deviations including associated root cause analysis, CAPAs, and effectiveness checks. * Provide input and updates into the quality sections of the Pharmacovigilance System Master File. * Perform quality control activities, as appropriate, to ensure accuracy of the data within the quality sections of the PSMF. * Chips in to the creation and/or revision of procedural documents (i.e. Standard Operating Procedures, Work Instructions) and other PV-related documents (i.e. Joint Operating Guidelines, Quality Management Plans, Safety Data Exchange Agreements). * Participates in Regulatory Authority inspections and assists with inspection readiness activities. Provide input, review and oversight of responses to inspection observations including any regulatory agency questions resulting from inspections. * Proactively identify and report systematic issues. * Lead and/or assist in operational continuous improvement initiatives to enhance processes for efficiency and effectiveness. * Provide support and training to other staff members to develop additional GVP expertise in quality and auditing resources.
Insmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most valuable resource is our employees, and everything we do is motivated by a patients-first mentality. We are dedicated to growing our team with talented individuals from around the world who are willing to challenge the status quo, solve problems, and work collaboratively with a sense of urgency and compassion. Guided by our core values of collaboration, accountability, passion, respect, and integrity, we aim to foster an inclusive, diverse, and flexible work environment, where our employees are recognized for leaning in and rolling up their sleeves. If you share our vision and want to work with the most dedicated people in the biopharma industry, come to Insmed to accelerate your career. Insmed is dedicated to creating a collaborative environment where our team can thrive. Every day, our employees turn their passion for science and research into innovative solutions for patients. That's why we've been named the No. 1 company to work for in the biopharma industry in Science's Top Employers survey for four years in a row. We are also honored to have been listed on the Best Workplaces in Biopharma, Best Workplaces in New York, PEOPLE Companies That Care, Best Workplaces for Women, Best Workplaces for Millennials, and Best Medium Workplaces lists. Reporting to the Sr Director, Quality Assurance - Pharmacovigilance, the Manager of Pharmacovigilance Quality Assurance serves as a strategic partner managing quality and regulatory compliance related to Good Pharmacovigilance Practices (GVP) and other related activities performed by Drug Safety & Pharmacovigilance (DSPV), Medical Information (MI), and Clinical Departments. The incumbent will provide support and promote collaboration with cross functional internal and external teams to ensure all systems, processes, and outcomes comply with applicable global standards, regulations, and guidelines. Responsibilities
* Support the evaluation and acceptability of vendors, partners, and other external organizations related to Pharmacovigilance (PV) activities such as Patient Support Programs, Specialty Pharmacies, and Market Research, for qualification. * Conduct and/or assist with the completion and evaluation of supplier pre-qualification surveys. * Creation and maintenance of vendor organization records related to PV activities in the QMS system. * Conduct internal and external risk assessments of PV process systems, vendors, partners, and other external organizations related to PV activities. * Provide input into the annual audit schedule for internal and external audits related to PV activities based on the output of the risk assessments. * Lead or co-lead internal and external pharmacovigilance audits (such as PV process systems, Patient Support Programs, Market Research, Specialty Pharmacies) including planning, execution, and reporting. * Communicates audit outcomes to collaborators and writes the audit report. * Assesses audit responses and ensures proposed corrective action preventative actions (CAPA) received by auditee(s) are adequate. * Provides oversight and monitoring to ensure timely closure of all CAPAs. * Review and approve internal and external deviations including associated root cause analysis, CAPAs, and effectiveness checks. * Provide input and updates into the quality sections of the Pharmacovigilance System Master File. * Perform quality control activities, as appropriate, to ensure accuracy of the data within the quality sections of the PSMF. * Chips in to the creation and/or revision of procedural documents (i.e. Standard Operating Procedures, Work Instructions) and other PV-related documents (i.e. Joint Operating Guidelines, Quality Management Plans, Safety Data Exchange Agreements). * Participates in Regulatory Authority inspections and assists with inspection readiness activities. Provide input, review and oversight of responses to inspection observations including any regulatory agency questions resulting from inspections. * Proactively identify and report systematic issues. * Lead and/or assist in operational continuous improvement initiatives to enhance processes for efficiency and effectiveness. * Provide support and training to other staff members to develop additional GVP expertise in quality and auditing resources.