Manager, Pharmacovigilance Platform Success

Back to Job Openings

Location :
Warrenville, IL

Job Title : Manager, Pharmacovigilance Platform Success

Direct Reports : Yes

• Lead kickoff and scoping. Run structured kickoff sessions to define implementation scope, success criteria, timelines, and key stakeholders.
• Design workflow configurations. Translate client safety workflows — case intake, processing, narrative writing, aggregate reporting — into platform configuration requirements aligned with their SOPs.
• Coordinate cross-functional delivery. Serve as the primary client contact across implementation, product, and technical teams to keep onboarding on track and escalations resolved quickly.
• Manage data migration and validation. Oversee migration of historical safety data, support UAT planning, and ensure client sign‑off on validated workflows before go‑live.
• Drive regulatory readiness. Ensure the configured platform meets 21 CFR Part 11, ICH E2B, and applicable FDA/EMA submission requirements before client go‑live.
• Capture lessons learned. Document post‑onboarding insights to continuously improve implementation playbooks and reduce time‑to‑value for future clients.

• Lead discovery conversations. Engage prospects in deep‑dive discovery to uncover safety operations pain points — processing backlogs, E2B compliance gaps, audit readiness, system fragmentation — and map them to Cloudbyz capabilities.
• Deliver tailored demos. Conduct platform demonstrations configured around prospect‑specific workflows, showing real PV use cases rather than generic product tours.
• Own RFP and RFI responses. Write and review PV‑specific sections of proposals, RFPs, and RFIs with accuracy, regulatory depth, and competitive clarity.
• Build the business case. Develop ROI models and value narratives quantifying efficiency gains, headcount optimization, and audit risk reduction to support deal progression.
• Address technical and compliance objections. Serve as the authoritative voice on validation, data privacy, 21 CFR Part 11 compliance, and integration architecture during the sales cycle.
• Support contract scope definition. Collaborate with account executives to define implementation scope, resource estimates, and onboarding timelines that feed into commercial proposals.

• Write expert content. Author blogs, white papers, and solution briefs on ICSR automation, E2B(R3) compliance, AI in pharmacovigilance, and CRO safety operations efficiency.
• Speak at webinars and events. Represent Cloudbyz as a subject matter expert at virtual webinars, industry conferences (DIA, RAPS), and partner events — presenting original insights, not product pitches.
• Support campaign development. Partner with the marketing team to develop messaging, personas, and campaign assets for PV‑segment outreach targeting safety leads at pharma, biotech, and CROs.
• Develop case studies. Work with satisfied clients post‑onboarding to document measurable outcomes and co‑create reference stories that support pipeline generation.
• Monitor competitive and regulatory landscape. Stay current on evolving EMA/FDA safety reporting guidance and competitor positioning; feed insights into marketing messaging and sales enablement.

• Translate client needs into requirements. Synthesize feedback from onboarding, support escalations, and sales cycles into structured product requirements — use cases, acceptance criteria, and priority rationale.
• Validate feature designs. Review…