Opella is a global leader in self-care, offering a diverse portfolio of Over-The-Counter (OTC) and Vitamins, Minerals & Supplements (VMS) products. With a mission to simplify self-care for over half a billion consumers worldwide, Opella is home to renowned brands like Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale, and Mucosolvan.
Headquartered in France, Opella operates across multiple markets with 11,000+ employees, 13 manufacturing sites, and four innovation centers. As a B Corp-certified company, Opella is committed to fostering healthier people and a sustainable planet.
🔗 Learn more: www.opella.com
Job Description
Key Responsibilities:
The Pharmacovigilance Periodic Reporting Oversight Specialist will oversee regulatory compliance and safety reporting for Opella’s global pharmacovigilance operations.
Regulatory & Process Oversight:
- Ensure compliance with ICH, GVP, CFR, and other global pharmacovigilance regulations for Periodic Safety Reports (PSRs).
- Act as the Opella PV representative in audits and inspections, explaining PSR processes.
- Collaborate with Global Safety Officers (GSO), QPPV, and Risk Management teams to respond to Health Authority assessments.
- Maintain continuity in safety messaging across regulatory documents (RMP, DSUR, RSI).
Project Management & Cross-functional Coordination:
- Lead authoring and submission of PBRERs, DSURs, and other periodic reports.
- Manage vendor oversight for outsourced PSR activities, ensuring quality and compliance.
- Track KPIs, quality metrics, and compliance trends for periodic reports.
- Drive process improvements and update quality documents (QDs) as per regulatory changes.
Stakeholder & Vendor Management:
- Conduct kick-off meetings and ensure adherence to timelines.
- Provide training and support to internal teams and external vendors.
- Address Health Authority queries related to PSR content and processes.
Qualifications & Skills
Experience Required:
- 5-6 years in Pharmacovigilance, specializing in aggregate safety reports (PBRER, DSUR, PSUR).
- Strong project management skills with the ability to multitask.
- Expertise in ICH, GVP, and global PV regulations (EU, US, China, Japan, Brazil).
- Experience with safety databases (Aris-G, Argus, VigiBase).
Technical Skills:
- Regulatory compliance (GxP, safety reporting).
- Business Intelligence tools (Power BI, Spotfire).
- Report writing & data analysis.
- User Acceptance Testing (UAT) for PV systems.
Soft Skills:
- Strong communication & negotiation skills.
- Problem-solving & attention to detail.
- Ability to work in a cross-functional, multicultural environment.
Education:
- Bachelor’s/Master’s in Life Sciences, Pharmacy, or related field.
- Fluent in English (verbal & written).
Why Join Opella?
At Opella, you’ll work in a dynamic, inclusive culture that encourages innovation and growth. The company values:
✅ All In Together – Collaborative and transparent work environment.
✅ Courageous – Encourages creative risk-taking.
✅ Outcome-Obsessed – Focus on sustainable impact.
✅ Radically Simple – Making self-care easy for consumers.
