Manager, Pharmacovigilance Platform Success

Cloudbyz; Warrenville (IL); On-site; USD 140,000 - 190,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Pharmacovigilance

Client-facing

Leadership

Pre-sales & Demos

Education

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

Advanced degree a plus

Tools

Argus

Veeva Vault Safety

ARISg

Job description

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Manager, Pharmacovigilance Platform Success

Location : Warrenville, IL

Job Description

Job Title : Manager, Pharmacovigilance Platform Success

Direct Reports : Yes

Primary Responsibilities

Client Onboarding: Own the client journey from contract signature to live platform

• 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.

Pre‑Sales Support - Turn domain credibility into closed deals

• 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.

Marketing and Thought Leadership - Build Cloudbyz's authority in the PV space

• 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.

Product Roadmap SME - Shape the platform from the inside

• 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 wireframes, workflow mockups, and release candidates from a PV practitioner’s perspective before development is finalized.
• Represent regulatory requirements. Ensure upcoming features remain aligned with ICH E2B, MedDRA, WHO Drug standards, and applicable FDA/EMA electronic reporting requirements.
• Prioritize with context. Bring market and competitive intelligence into quarterly roadmap planning sessions to distinguish high‑impact improvements from nice‑to‑haves.
• Support release communications. Contribute to release notes, internal training materials, and client‑facing announcements for new PV platform capabilities.

Education

• B.S. in health professions, life sciences, pharmacy, or related field; advanced degree a plus.
• Experience with life sciences SaaS platforms, particularly on Salesforce, is a strong advantage.

Experience

• 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.

Additional Skills

• Excellent written communication skills; ability to translate technical safety concepts for non‑technical audiences.
• Ability to work autonomously in a fast‑paced environment, managing multiple priorities without losing sight of the commercial goal.
• Excellent leadership, management, and interpersonal skills.

This job description should not be deemed all-inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company defined policies and company SOPs.