Manager, Pharmacovigilance Platform Success

Manager, Pharmacovigilance Platform Success

Location: Warrenville, IL

Job Title: Manager, Pharmacovigilance Platform Success

Direct Reports: Yes

Primary Responsibilities

Client Onboarding

• 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

• 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

• 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

• 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.