Patient Safety Specialist
Warsaw, PL, 02-653
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to win in self-care.
Description Overview
As a major player in consumer health and cosmetics, Perrigo is an American pharmaceutical company committed to supporting the health and well-being of consumers through a unique portfolio of market-leading brands.
Our vision is to make lives better by bringing Quality, Affordable Self-Care Products that consumers trust everywhere they are sold.
As part of the Global Patient Safety team, you will assist with investigations and documentation of quality related complaints, inquiries, requests for assistance from consumers, customers, regulatory agencies, and 3rd party product assessments concerning Perrigo drug products per regulatory requirements
Scope of the Role
1.Coordinate the preparation of PSURs, Addenda to Clinical Overviews (ACOs) for renewals, and Risk Management Plans (RMPs) in accordance with applicable procedures and within internal and regulatory deadlines; track progress and ensure timely completion.
2. Author, review and/or provide input to PSURs, RMPs and ACOs for renewals, including quality checks before finalisation.
3. Review the results of global and local literature searches, as applicable to assigned products and activities.
4. Maintain aggregate safety report planning, including PSURs and ACOs for renewals.
5. Participate in the preparation, writing and/or review of ACOs for variations.
6. Participate in the review of Company Core Safety Information (CCSI).
7. Review and/or provide safety input for SmPC and PIL creation or updates.
8. Prepare for, participate in and present relevant topics at Safety Committees and the Global Safety & Labeling Council.
9. Draft responses or contribute to the preparation of responses to Health Authority requests for information related to patient safety topics.
10. Participate in signal detection activities, including signal validation and full signal assessment, as applicable.
11. Participate in the reconciliation of literature and signal activities, where required.
12. Contribute, where applicable, to the handling of medical information enquiries and the review of FAQs.
13. May be involved in the coordination and preparation of PSURs and trending reports for non-medicinal products and follow up on related action items.
14. Organise and participate in cross-functional meetings related to safety topics.
15. Provide input to the Pharmacovigilance System Master File (PSMF), including relevant annexes.
16. Draft, update and review Global Patient Safety SOPs, work instructions and related controlled documents.
17. Prepare presentations and provide training on relevant patient safety processes and activities.
18. Support the management and follow-up of non-conformances, CAPAs and KPIs related to assigned activities.
19. Support regulatory inspections, audits and inspection-readiness activities.
20. Participate in regulatory intelligence activities relevant to benefit-risk evaluation and patient safety responsibilities.
Experience Required
Master’s degree in life sciences, pharmacy, medicine or another relevant scientific discipline.
Minimum of 2 years of experience in pharmacovigilance, patient safety, medical writing or a related regulatory/scientific role, preferably in an international environment
• Ability to coordinate activities and act as a subject matter expert within assigned areas.
• Experience in medical writing, aggregate safety reports, signal management or risk management is an asset.
• Strong analytical skills, process mindset and attention to detail.
• Ability to work effectively in a matrix and cross-functional environment while remaining organised and deadline-driven.
• Demonstrates initiative, ownership and the ability to work under pressure.
• Hands-on mindset with a proactive and continuous-improvement attitude.
• Fluent in English, with strong written and verbal communication skills.
• Good understanding of applicable pharmacovigilance regulatory requirements and quality expectations.
Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
Find out more about Total Rewards at Perrigo.
Hybrid Working Approach
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.
We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here
Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) All application materials, including resumes and CVs, must be submitted in English. Thank you.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo