Qinecsa Solutions
Website:
qinecsa.com
Job details:
About Qinecsa Solutions
Qinecsa Solutions is a PE-backed pharmacovigilance SaaS company, purpose-built for the global drug safety market. Our product portfolio spans the full PV lifecycle: Reportum (case intake), HaloPV (end-to-end PV operations), QVW / Vigilance Workbench (signal detection and management — all underpinned by a Trust-Layered Architecture and PV AI Governance Framework that are provisionally filed as proprietary IP.
Our vision — Safety without seams. From molecule to patient, and back — reflects our belief that pharmacovigilance should be a strategic capability, not a compliance cost centre. We are building the platform that makes that vision real
About this Opportunity
Qinecsa Solutions is a purpose-built pharmacovigilance (PV) SaaS company, helping pharmaceutical and biotechnology organizations manage patient safety operations from case intake to signal detection. Our flagship product, Reportum, is the market-leading safety case intake platform — processing adverse event reports at scale, with an AI layer (Reportum AI) that is setting the standard for intelligent, governance-assured automation in pharmacovigilance.
We are looking for a Senior Director of Product Management to help shape the Reportum product strategy and roadmap, in close partnership with the VP of Product. This is a high-visibility role at the heart of Qinecsa's growth strategy — Reportum is one of the commercial anchors of our portfolio, the primary driver of new customer acquisition, and the product through which we are demonstrating what responsible AI in pharmacovigilance looks like in practice.
This is not a maintenance role. You will be joining a strong technical foundation, with a mandate to help take Reportum from a well-regarded intake platform to an indispensable part of the global PV operating model. You will help shape the vision and the roadmap, engage with senior internal and external stakeholders, and help shape
the commercial and strategic narrative along with the VP of Product that positions Reportum as the category leader.
About Reportum
Reportum is Qinecsa's safety case intake platform, used by pharmaceutical companies globally to receive, triage, and process adverse event reports in compliance with ICH E2B and regional regulatory requirements. It handles structured and unstructured data across multiple intake channels — E2B, web, mobile, fax — and routes cases to downstream safety systems including Oracle Argus, ArisGlobal, and Qinecsa's own HaloPV platform.
Reportum AI is the AI layer embedded within Reportum, designed to assist with case triage, narrative extraction, and seriousness assessment. Reportum AI is built on a Trust-Layered Architecture — a proprietary framework co-developed by Qinecsa's product and AI engineering teams that places deterministic safety controls, confidence
gates, and human oversight at the core of every AI-assisted decision. This is Qinecsa's primary AI differentiator in the market and a key area of your ownership.
What You Will Own
Product Strategy and Roadmap
- Help shape the multi-year product strategy for Reportum and Reportum AI, in close partnership with the VP of Product, aligned to Qinecsa's broader Continuum portfolio vision
- Help translate market intelligence, customer insight, and regulatory trends into a clear, prioritised roadmap that creates measurable commercial value
- Help with roadmap governance through the Product Advisory Council (PAC) and Product Strategy Board (PSB), ensuring customer influence is structured and commitments are defensible
- Position Reportum competitively against Oracle Argus, ArisGlobal (now Dassault), and emerging AI-native entrants
Delivery Execution
- Own day-to-day backlog management and sprint delivery for Reportum, working directly with engineering and QA to keep releases on track
- Act as the hands-on product owner for release cycles, including requirements detail, acceptance criteria, and day-to-day triage of delivery issues
- Partner closely with the VP of Product on prioritization and sequencing, ensuring strategic roadmap decisions translate cleanly into executable sprint plans
AI Product Leadership
- Own the product definition and governance framework for Reportum AI — Qinecsa's AI-assisted case processing capability
- Ensure Reportum AI's Trust-Layered Architecture is maintained and evolved in line with emerging regulatory guidance (EU AI Act, FDA-EMA Joint Guiding Principles, CIOMS Working Group XIV)
- Collaborate with the AI Engineering COE to translate AI capability into validated, commercially deployable product features
- Support the VP of Product in representing Qinecsa's AI governance approach externally — at industry events, in customer conversations, and in regulatory engagements
Customer and Commercial Engagement
- Engage directly with stakeholders at pharmaceutical customers and prospects — including design partner conversations, roadmap reviews, and procurement support
- Work with the commercial team to help develop commercial narratives, RFP responses, and differentiation materials for Reportum
- Build and maintain relationships with Qinecsa's Product Advisory Council members, running structured feedback cycles that inform roadmap decisions
- Support customer health and retention by ensuring Reportum delivers measurable operational value and proactive product support
Cross-Functional Leadership and Influence
- Operate as a senior product authority for Reportum, alongside the VP of Product — a go-to expert for engineering, UX, commercial, and executive stakeholders on matters of product strategy, architecture, and AI governance
- Mentor and elevate the product thinking of Reportum Product team without formal management accountability — sharing expertise, reviewing roadmap decisions, and raising the bar on product craft across the team
- Lead major cross-functional initiatives — from new capability launches to integration programs — bringing together engineering, QA, and delivery around the initiatives
- Represent Reportum and Qinecsa externally at industry events, regulatory forums, and customer advisory sessions, in partnership with the VP of Product
What We Are Looking For
Experience
- 12+ years of product management experience, with a track record of operating at Senior Director or Principal level as an individual contributor — influencing strategy and leading programs
- Deep domain expertise in pharmacovigilance, drug safety, or regulatory affairs — you understand ICSR processing, E2B standards, aggregate reporting, and the operational realities of a PV department
- Demonstrated track record of owning a complex, enterprise B2B SaaS product from strategy through delivery — including roadmap governance, customer engagement, and commercial outcomes
- Experience leading AI or ML-enabled product development in a regulated environment — with genuine understanding of validation, auditability, and human-in-the-loop design principles
- Comfortable operating with pharmaceutical VPs and C-suite stakeholders — you have run customer advisory sessions, supported major RFPs, and translated customer insight into product strategy
- Comfortable operating inside an agile delivery model — running or working closely within sprint cycles, backlog grooming, and release planning, with the judgement to know when hands-on delivery work takes priority over strategic work
Competency Profile
This role maps to Qinecsa's Senior Director (M8/P8) level in our Product Competency Framework. We expect candidates to demonstrate:
- Domain Expertise at industry-authority level — you are a recognized expert in pharmacovigilance product function and can represent Qinecsa at customer forums, industry events and regulatory forums
- Product Strategy & Vision at portfolio level — you help the VP of Product set and execute direction across a multi-year roadmap, help weigh revenue implications of prioritization decisions, and define competitive positioning
- Requirements & Design at architectural scale — you design end-to-end case processing workflows, make cross-system integration decisions, and set the standard for your team's requirements practice
- Business Impact & Value — you have product P&L thinking, define ROI frameworks for new features, and connect roadmap decisions to ARR growth and customer retention
- Influence without authority — you lead through expertise, shape product decisions across the organization, and bring engineering, UX, commercial, and leadership stakeholders into alignment without formal people management responsibility
- Go-To-Market strategy — you help develop and own the GTM narrative for Reportum, in partnership with VP of product, Marketing and commercial team
What Will Set You Apart
- Prior experience with Oracle Argus, ArisGlobal, or comparable enterprise PV platforms — either as a product leader at the vendor or as a senior operator at a pharma company
- Understanding of AI governance frameworks in regulated industries and the ability to engage credibly with regulators and customers on responsible AI deployment
- Experience in a PE-backed or growth-stage SaaS company — you know how to operate with urgency, manage competing priorities, and deliver in a fast-moving environment
- Familiarity with the Pragmatic Institute product management framework or comparable structured PM methodology
What Qinecsa Offers
- A high-impact role at the center of Qinecsa's growth strategy — Reportum is one of our commercial anchors, and Reportum AI is our AI flagship
- The opportunity to help shape what responsible AI in pharmacovigilance looks like — working alongside a world-class AI Engineering team with a proprietary governance architecture
- Close collaboration with product leadership, with direct exposure to senior leaders andkey customer conversations
- A collaborative, mission-driven culture where patient safety is the north star
- Competitive compensation and benefits, commensurate with a senior director role in a PE-backed technology company
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