Job title : Digital Science Functional Expert —Pharmacovigilance
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people' s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.
Headquartered in France, Opella is the proud maker of many of the world' s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com .
The Digital Functional Expert — Pharmacovigilance, within the Digital Health & Science Global function at Opella, supports the person accountable for Pharmacovigilance (PV) digital platforms by contributing to the end‑to‑end product lifecycle and ensuring alignment with functional, regulatory, and operational needs.
He/She ensures that the systems, projects, and processes supporting Drug Safety align with business objectives, regulatory requirements, and the needs of PV teams globally.
This role acts as the critical bridge between Pharmacovigilance business stakeholders, software vendor (Aris Global), regulatory authorities, and digital/IT development teams — facilitating effective communication, decision-making, and continuous improvement across the full digital ecosystem.
Product Backlog & Delivery Support
Lead the definition and maintenance of the product backlog for Pharmacovigilance platforms (LSMV, Navax, Signal / Aris Global), translating business requirements into well-defined user stories, epics, and acceptance criteria.
Write functional specifications and ensure stories are ready for development (Definition of Ready) and meet quality standards upon delivery (Definition of Done).
Track and monitor delivery progress, flagging risks or blockers to the Business Owner.
Support issue resolution in line with Support governance, acting as a first point of contact for functional queries related to PV features.
Pharmacovigilance Systems — Solution Enablement
Drive the continuous improvement of LSMV (Aris Global) to support end-to-end PV operations: Individual Case Safety Report (ICSR) management, signal detection and management, aggregate safety reporting (PSUR/PBRER/DSUR), and health authority submission workflows.
Support the configuration, validation, and lifecycle management of LSMV (Aris Global) to ensure compliant adverse event intake, processing, medical coding (MedDRA), narratives, and E2B submissions in line with ICH E2B(R3), EMA, and FDA requirements.
Ensure that all PV systems comply with applicable regulations: GVP modules, ICH guidelines, 21 CFR Part 11, and EMA/FDA digital submission requirements.
Participate in UAT cycles and system validation (CSV/GxP validation) for PV systems, coordinating with Digital Quality, Security and Infra teams and PV Operations.
Support countries and PV team members in adopting and using PV digital tools, ensuring proper training and change management.
Vendor & Support Coordination
- Act as a point of contact for day-to-day coordination with Digital Science vendors and AIMS on functional topics, ensuring support tickets SLAs are respected.
- Escalate recurring issues and contribute to continuous improvement initiatives with vendors and internal technical teams.
B — Product Governance & Stakeholder Engagement
- Handle product governance, ensuring the product roadmap is delivered on time and aligned with business expectations.
- Maintain product documentation, user guides, release notes, and training materials for medical and pharmacovigilance capabilities.
- Liaise with PV teams to gather end users feedback, usage insights, and prioritization inputs from business teams.
- Monitor product performance metrics and user adoption
Education
Bachelor's or Master's in Business, Information Systems, Science or equivalent.
Experience
3–5 years as a Junior Product Owner, Business Analyst, or in a digital product/project role. Agile and AI exposure is a plus.
Experience working in global teams and supporting business customers across multiple countries and cultures.
Pharmacovigilance
Good knowledge of safety process, Aris Global solutions. Proven experience in supporting PV solutions.
Agile & Data
Familiarity with Scrum/Agile, Jira, and Confluence; comfort with KPI tracking and reporting tools.
- Proactive and autonomous — able to manage multiple priorities in a global, matrixed organization.
- Clear communicator, adaptable to field, product, technical, and science audiences.
- Detail-oriented with genuine curiosity for science topics, PV and Medical Affairs technologies.
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.
www.opella.com/en/careers
