[Hiring] Manager, Pharmacovigilance reputed company Assurance @reputed company

Role reputed company Reporting to the Sr Director, reputed company Assurance - Pharmacovigilance, the Manager of Pharmacovigilance reputed company Assurance serves as a strategic partner managing reputed company and regulatory compliance reputed company to Good Pharmacovigilance Practices (GVP) and other reputed company activities performed by Drug Safety & Pharmacovigilance (DSPV), Medical Information (MI), and Clinical Departments. The incumbent will reputed company support and promote collaboration with cross functional reputed company teams to ensure reputed company systems, processes and reputed company reputed company with applicable global standards, regulations and guidelines. What You'll Do:

• Support the evaluation and acceptability of vendors, partners and other external organizations reputed company to Pharmacovigilance (PV) activities.
• Conduct and/or assist with the completion and evaluation of supplier reputed company-qualification surveys.
• Create and maintain vendor organization records reputed company to PV activities in the QMS system.
• Conduct reputed company risk assessments of PV process systems, vendors, partners, and other external organizations reputed company to PV activities.
• reputed company input into the annual audit schedule for reputed company audits reputed company to PV activities based on the reputed company of the risk assessments.
• reputed company or co-reputed company reputed company pharmacovigilance audits including planning, execution, and reporting.
• Assess audit responses and ensure proposed corrective reputed company preventative actions (CAPA) received by auditee(s) are adequate.
• Review and approve reputed company deviations including associated reputed company cause analysis, CAPAs, and effectiveness checks.
• reputed company input and updates into the reputed company sections of the Pharmacovigilance System Master File.
• Contribute to the creation and/or revision of procedural documents and other PV-reputed company documents.
• Participate in Regulatory Authority inspections and assist with inspection readiness activities.

Qualifications

• Minimum BS degree in reputed company, Biology or reputed company life sciences field required.
• Minimum 3 years of experience in pharmaceutical industry, 2 years of which are pharmacovigilance and/or GVP reputed company Assurance.
• Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience.
• Requires experience with pharmacovigilance in Phases I-IV and post-marketing.
• Broad knowledge and understanding of global pharmacovigilance regulations and guidelines, including FDA, EMA and ICH regulations.
• Experience in leading and/or conducting reputed company audits.
• Knowledge of Adverse Event (AE) reporting requirements and pharmacovigilance principles.
• Knowledge of vendor management and contract management reputed company to PV activities.
• Experience developing and reviewing procedural documents to ensure global regulatory expectations are met.
• Experience with CAPA management and issue reputed company.
• Broad knowledge of risk-based reputed company systems approaches consistent with post-marketing Good Pharmacovigilance Practices.

Requirements

• Fully remote role; can be performed from reputed company while staying connected to the reputed company team.
• Occasional travel for team meetings or events may be expected.
• Minimal travel expected.

Benefits

• Comprehensive medical, dental, and reputed company coverage and mental health support.
• Generous reputed company time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP).
• Company Learning Institute providing reputed company to reputed company Learning, reputed company building workshops, leadership programs, mentorship connections, and networking opportunities.
• Employee resource reputed company, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back.

Apply tot his job Apply To this Job