Patient Safety Specialist

Perrigouk; Warszawa; On-site; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Hybrid work allowing two days fromhome

Career development potential

Equal opportunity employer

Job summary

Perrigo is seeking a Pharmacovigilance professional to join our Global Patient Safety team in Warsaw. You will help manage PSURs, RMPs and related safety documentation, coordinating with cross-functional groups to ensure timely and compliant delivery.

Your role includes literature review, signal management, and drafting responses for health authorities. We value practical, proactive individuals with a master’s degree in life sciences and at least two years in pharmacovigilance or related

Qualifications

• Master's degree in life sciences, pharmacy, medicine or a related scientific field.
• Minimum 2 years in pharmacovigilance, patient safety or a regulatory role, ideally international.
• Strong writing, data analysis and regulatory knowledge intended for safety activities.

Responsibilities

• Coordinate preparation of PSURs, ACOs and RMPs within procedures and deadlines.
• Author/review input to PSURs, RMPs and ACOs with quality checks.
• Review literature and perform searches relevant to assigned products.
• Maintain safety reporting plans including PSURs/ACOs for renewals.
• Prepare/review ACOs for variations and CCIS-related inputs.
• Review safety information and SmPC/PIL updates as needed.
• Participate in Safety Committees and Global Safety & Labeling Council presentations.
• Draft responses to Health Authority information requests on patient safety topics.
• Engage in signal detection, validation and full assessment.
• Coordinate literature/signal reconciliation as required.
• Support medical information inquiries and FAQs.
• Coordinate PSURs/trending reports for non-medicinal products as needed.
• Organise cross-functional safety topic meetings.
• Contribute to Pharmacovigilance System Master File (PSMF) and annexes.
• Draft/update safety SOPs and related documents.
• Prepare trainings on patient safety processes and activities.
• Support CAPAs, KPIs, non-conformances and audits readiness.
• Assist regulatory inspections and intelligence activities related to benefit-risk.

Skills

Coordination

Medical writing

PSURs

Literature review

Risk management

Analytical skills

Cross-functional teamwork

Deadline-driven

Proactive mindset

Fluent English

Education

Master's degree in life sciences, pharmacy, medicine

Job description

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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, preferable 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.

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 morehere

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