Specialist Patient Safety/Pharmacovigilance

Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it.
External 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.) Thank you.
Description Overview
Receives, investigates and responds to adverse event/adverse experience reports, ensuring compliance with the Company's investigation, documentation, and regulatory reporting, procedures.
Scope of the Role
• Receives and evaluates adverse drug experience and/or product complaints on OTC and prescription products, and performs follow up with consumers and healthcare professionals for the purpose of completing case documentation.
• Assists international sites with preparation and review of adverse event reports and periodic safety update reports (PSUR).
• Interacts with partners to exchange required safety data, with Consumer Affairs department on quality related investigations of adverse events, and with Regulatory Affairs for Annual Reporting, labeling, and other product related issues.
• Ensures data accuracy, clinically valid case assessment, and regulatory reporting status assessment, and identifies and processes serious or expedited reports for evaluation and reporting.
• Assists call center personnel in responding to medical inquiries and prepares written responses to complaints, assists with searches and interpretation of scientific literature for adverse event reports and the Legal Department when requested with specific searches and evaluation.
• Prepares and reviews FDA MedWatch, ICH CIOMS forms, and other required regulatory reporting forms, codes adverse event terms in MedDRA, prepares and/or reviews quarterly and annual safety reports for submission to the FDA, and reviews and provides feedback on creation of Pharmacovigilance agreements with 3rd parties
Experience Required
University Degree; Typically a minimum of 4 years work experience required
External 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.) Thank you.
We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team's differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,' veterans status', military status' and more are encouraged to apply. TOGETHER, we make lives better. #DIV