It all started with a pharmacist and a dream 140 years ago. Today, Beiersdorf is a global company with iconic brands — Coppertone, Aquaphor, Eucerin, Elastoplast and NIVEA — focused on providing innovative, clinically-proven and safe skin and sun care solutions to more than 500 million consumers in over 200 countries — making people feel comfortable in their own skin.
At Beiersdorf, we care beyond skin. We care for people — our employees, our customers, our consumers and our communities — and our planet. We know that diversity of thought, backgrounds, experience, and perspective enriches our culture and fosters innovation and ingenuity. We know that responsibly sourced, sustainable products and packaging make for a more sustainable future. And we know that when your skin feels better, you feel better.
This position includes direct involvement of Quality and Regulatory troubleshooting. Reporting to the Head of RA/QA, the successful candidate will have working knowledge of Canadian regulatory and quality requirements and must be able to manage and coordinate pharmacovigilance for Canada, US and Beiersdorf global, including for Nivea and Coppertone. The role is divided into 3 parts of responsibilities (QA 50%, RA 20% and PV 30%).
Quality Assurance responsibilities (50%)
- Product releases in SAP system
- Obtaining required documents from manufacturing sites to release products
- Managing CAPAs
- Preparing investigation reports to be performed at warehouse, manufacturing sites
- Preparing monthly quality reports that reflect consumer and customer complaints, OSQ and Audit Plans
- Helping ensure that Global/Regional BDF QA requirements are implemented
- Assisting in performing quality store checks on an ongoing basis, documenting deficiencies, and preparing reports and assisting Quality management in the quality on shelf corporate initiative
- Evaluating destruction criteria for DIN and NHP returns through Phoenix system
- Contributing to continuous Improvement initiatives and participating in risk identification and contingency planning activities
- Supporting Sales with registering products at retail (W-M, SDM excel document)
- Supporting Customer Service with enquiries
- Providing VAS Production for Coppertone release timelines and interfacing with logistics/manufacturing/planning
Regulatory Affairs responsibilities (20%)
- Reviewing labels and advertising materials including print, digital etc for Regulatory compliance
- Preparing licensing submission documents and compiling and preparing DIN/NHP guidance’s for launches
- Assisting in managing claims support and interfacing with Hamburg, US and Coppertone R&D department
- Assisting in training BDF employees and external agencies
Pharmacovigilance responsibilities (30%)
- Handling pharmacovigilance for Canada and supporting the Head of RA/QA in the investigation of consumer complaints and/or adverse events
- Processing of individual case safety reports, and basic knowledge in aggregate reports, ICSRs, DSURs, in compliance with Regulatory authorities
- Providing monthly Reverse Supply Agreement reports
- Supporting PV Audit preparation
- Monthly meeting with Med Affairs for AE reported in US and Canada
- Generating monthly AR reports to Med Affairs
- Providing training on PV to BDF Canada employees