QMS and PV Compliance Manager

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians.  If you want to be part of this exciting work, you belong at Astellas! 

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com. 

Astellas’ Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands. Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients

Purpose and Scope:

• Perform PV Compliance related tasks systematically and effectively while complying with PV related local regulations, procedural documents, and job aids.
• Interface directly with internal PV and non-PV subject matter experts, including the PV responsible staff in the Affiliates, PV case management, PV case processing vendors and CROs and other Astellas partners, including Quality Assurance and Regulatory Affairs.
• Ensure PV audit and inspection readiness, as well as compliance with all applicable worldwide pharmacovigilance regulations.
• Support communication and collaboration across global PV teams and contribute to continuous inspection readiness and risk mitigation strategies.

Responsibilities and Accountabilities:

• Perform root case analysis (RCA) for ICSRs submitted late to health authorities, CROs and business partners.
• Perform data entry of RCA conclusions into the global safety database.
• Perform QC of data.
• Manage Excel-based spreadsheet RCA tracking tool.
• Manage weekly/bi-weekly meetings with case processing vendor(s) to discuss and resolve RCA.
• Attend periodic Compliance team meetings, teleconferences, and/or project team meetings with globally located colleagues.
• Support PV, including local affiliate staff, before, during and after, internal audits and external Health Authority inspections, local affiliate audits, license partners audits and local PV inspections, including onsite support if required and co-located.
• Monitor and contribute to preparation of compliance metrics and escalate trends or issues to PV leadership as appropriate.
• Participate in project improvement activities.
• Maintain timely and effective communications among cross-functional PV team members, vendors, and business partners.

Required Qualifications:

• 4-year degree (Bachelors)
• Minimum of 6 years in pharmaceutical, biotechnology, or related industry,
• Minimum 4 years significant experience in Pharmacovigilance, Regulatory Affairs or Quality Assurance,including establishing standards and metrics in support of quality systems.

Preferred Qualifications:

• Direct pharmacovigilance experience working in a Quality or Compliance role.
• Advanced Excel skills, including development/usage of formulas and macros, Power BI or similar.
• Strong experience conducting root cause analysis and implementing Corrective and Preventive Actions
• Proven ability to lead or facilitate cross-functional meetings with internal stakeholders and external partners/vendors.
• Familiarity with global pharmacovigilance regulatory requirements and audit/inspection processes