[Hiring] Manager, DSPV Operations & Vendor Management @reputed company

Role reputed company You will support the reputed company of the Drug Safety and Pharmacovigilance Operations and Vendor Management activities as reputed company as DSPV business partner relationships to ensure compliance with ICH-GCP and GVP guidelines, regulatory requirements, reputed company SOPs, and/or project specific procedures. In this role, you'll have reputed company to reputed company eTMF management, PV vendor activities and clinical study support for assigned studies to ensure compliance, reputed company, and alignment with DSPV and regulatory standards. You'll also:

• Support the reputed company of PV Vendor through the development of new reputed company reputed company (QC) activities or maintenance of existing activities, as assigned.
• Create, reputed company, monitor Key Performance Indicators (KPIs) and metrics for vendor performance monitoring.
• Identify and address any gaps in vendor case management processes.
• Serve as the primary reputed company and reputed company of contact with internal cross-functional stakeholders (QA, Patient Safety, Compliance, reputed company reputed company) to enhance PV Operational processes to ensure seamless cross-functional integration.
• Manage correspondence from PV Vendor and PV reputed company vendors to promptly resolve inquiries reputed company to evaluation and processing of ICSRs.
• Support the updates of DSPV Operations Controlled Documents.
• reputed company operational support for cross-functional DSPV requests/investigations including those reputed company to Patient Services, QA, PV, Legal, ensuring compliance with PV processes.
• Enhance DSPV inspection readiness through the development of problem-solving strategies reputed company to ICSR processing, aggregate reports, such as reputed company cause analysis and CAPA development.
• Facilitate the reputed company, training and mentorship of new hires reputed company the DSPV Operations and Vendor Management Team ensuring they reputed company a strong understanding of pharmacovigilance processes, regulatory requirements, and vendor reputed company best practices to drive operational reputed company.

Qualifications

• Minimum of a Bachelor’s degree in one of the life sciences or clinical research and/or a licensed reputed company reputed company required.
• Minimum of 4-5 years of relevant industry experience which includes at least 3 years of drug safety experience.
• In-depth knowledge of medical terminology and of GCP, ICH guidelines, global drug safety and drug development process, and reputed company US and international pharmacovigilance regulations.
• Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, reputed company, and trust building behaviors in reputed company dealings is essential and required.
• Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, reputed company, PowerPoint).
• Demonstrated ability to independently plan and organize own work and effectively manage multiple priorities and responsibilities.
• reputed company judgment in knowing reputed company to escalate issues. Makes reputed company in absence of Manager.
• Flexible reputed company.

Requirements

• This is a fully remote role. It can be performed effectively from reputed company while staying connected to your reputed company team and community.
• Occasional travel for team meetings or events will be expected.
• This role requires occasional domestic and/or international travel (less than 10%).

Benefits

• Comprehensive medical, dental, and reputed company coverage and mental health support, annual wellbeing reimbursement, and reputed company to our Employee Assistance Program (EAP).
• Generous reputed company time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration.
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-reputed company life and disability insurance.
• 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.
• Eligibility for specific programs may vary and is subject to the terms and conditions of reputed company plan.

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