Manager, DSPV Operations
Insmed Incorporated
•Onsite
About The Position
Supports the oversight of the Drug Safety and Pharmacovigilance Operations and Vendor Management activities as well as DSPV business partner relationships ensuring compliance with ICH-GCP and GVP guidelines, regulatory requirements, Insmed SOPs, and/or project specific procedures.
Requirements
- Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional 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 current US and international pharmacovigilance regulations.
- Good interpersonal, written, and verbal communication skills.
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
- Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
- Leads initiatives locally and globally.
- Ability to independently plan and organize own work and effectively manage multiple priorities and responsibilities.
- Demonstrates personal accountability for taking actions that drive business decisions.
- Displays sound judgment in knowing when to escalate issues.
- Makes sound decisions in absence of Manager.
- Builds and maintains relationships with peers and superiors.
- Recognizes impact of work on other functional areas and interdependencies.
- Embraces tough challenges with confidence, enthusiasm, and optimism.
- Must have a high degree of professionalism, and ability to work with limited direction.
- Self-motivated, with initiative and the ability to take ownership of, and follow through with, specific tasks.
- Flexible mindset.
Responsibilities
- Oversee eTMF management, PV vendor activities and clinical study support for assigned studies to ensure compliance, quality, and alignment with DSPV and regulatory standards.
- Support the oversight of PV Vendor through the development of new Quality Check (QC) activities or maintenance of existing activities, as assigned.
- Create, track, 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 liaison and point of contact with internal cross-functional stakeholders (QA, Patient Safety, Compliance, Commercial Strategy) to enhance PV Operational processes to ensure seamless cross-functional integration.
- Manage correspondence from PV Vendor and PV Related vendors to promptly resolve inquiries related to evaluation and processing of ICSRs.
- Support the updates of DSPV Operations Controlled Documents.
- Provide operational support for cross-functional DSPV requests/investigations including those related to Patient Services, QA, PV, Legal, ensuring compliance with PV processes.
- Enhance DSPV inspection readiness through the development of problem-solving strategies related to ICSR processing, aggregate reports, such as root cause analysis and CAPA development.
- Facilitate the onboarding, training and mentorship of new hires within the DSPV Operations and Vendor Management Team ensuring they develop a strong understanding of pharmacovigilance processes, regulatory requirements, and vendor oversight best practices to drive operational excellence.
Benefits
- Comprehensive medical, dental, and vision coverage and mental health support
- annual wellbeing reimbursement
- access to our Employee Assistance Program (EAP)
- Generous paid time off policies
- fertility and family-forming benefits
- caregiver support
- flexible work schedules with purposeful in-person collaboration
- 401(k) plan with a competitive company match
- annual equity awards
- participation in our Employee Stock Purchase Plan (ESPP)
- company-paid life and disability insurance
- Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
- Employee resource groups
- service and recognition programs
- meaningful opportunities to connect, volunteer, and give back
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What This Job Offers
Job Type
Full-time
Career Level
Manager
