Pharmacovigilance Platform Success Manager

Cloudbyz; Warrenville (IL); Presencial; USD 140.000 - 190.000; Jornada completa

Descripción de la vacante

Cloudbyz seeks a Manager, Pharmacovigilance Platform Success in Warrenville, IL to guide client onboarding from contract to live platform. You will lead kickoff sessions, map safety workflows to platform configurations, manage data migrations, and ensure regulatory readiness (21 CFR Part 11, ICH E2B, FDA/EMA).

You will collaborate with implementation, product, and technical teams, drive pre-sales support, and document lessons learned to shorten time-to-value for future clients.

Formación

• 7+ years in pharmacovigilance, drug safety, or lifecycle safety operations at a pharma, biotech, or CRO.
• Hands-on experience with case processing, signal management, and aggregate reporting (PSUR, DSUR, PBRER).
• Working knowledge of ICSR regulations: FDA 15‑day reporting, EudraVigilance, ICH E2B(R3), and MedDRA coding.
• Experience with safety platforms such as Argus, Veeva Vault Safety, or ARISg.
• Demonstrated client-facing or consulting experience — comfortable leading meetings, demos, and executive conversations.
• Prior involvement in pre-sales, solutions engineering, or RFP responses strongly preferred.

Responsabilidades

• Own the client journey from contract signature to live platform onboarding and success.
• Lead kickoff sessions, define scope, timelines, and stakeholders.
• Translate client safety workflows into platform configuration requirements.
• Coordinate with implementation, product, and technical teams to keep onboarding on track.
• Oversee data migration, UAT planning, and sign-off on validated workflows.
• Ensure 21 CFR Part 11, ICH E2B, FDA/EMA submission readiness before go-live.
• Capture lessons learned to improve playbooks and time-to-value.

Conocimientos

Pharmacovigilance

Client-facing

Leadership

Pre-sales & Demos

Educación

B.S. in health professions, life sciences, pharmacy, or related field

Advanced degree a plus

Herramientas

Argus

Veeva Vault Safety

ARISg

Descripción del empleo

Cloudbyz seeks a Manager, Pharmacovigilance Platform Success in Warrenville, IL to guide client onboarding from contract to live platform. You will lead kickoff sessions, map safety workflows to platform configurations, manage data migrations, and ensure regulatory readiness (21 CFR Part 11, ICH E2B, FDA/EMA).

You will collaborate with implementation, product, and technical teams, drive pre-sales support, and document lessons learned to shorten time-to-value for future clients.