Working at Horizon is more than a job - it's personal. For us, success is measured by the numbers that matter most - the number of lives we touch, the number we change and those we work tirelessly to help save. We're a team of agile, out-of-the-box thinkers who are inspired to do more because we know we're a part of something bigger. We strive to build meaningful careers at a company whose values we share because when we live up to our potential, we help others live up to theirs. Responsibilities:
- This Senior Associate, Clinical Safety Operations is expected to provide PV leadership and expertise over an assigned group of studies (Phases I-IV). Tasks include:
- Review the safety reporting section of protocols
- Develop and maintenance the SAE form for studies
- Develop and maintenance the Safety Management plan
- Support the eTMF safety sections
- Attend cross-functional study program meetings
- Support the Investigator meetings on topics such as the Study SAE reporting
- Oversee PV vendors activities:
- Run Argus reports (master Line Listing, open activities, submissions records)
- Receipt of SUSAR, SAE, AESI, process, review of SUSARs, quality check, support unblinding process, and distribution to regulatory authorities
- Manage ongoing training needs to PV Vendor
- Manage the SAE reconciliation process for all assigned programs monthly ensuring discrepancies are resolved
- Collaborate with PV compliance and governance on quality events relating to Clinical Safety Operations.
- Participate in process improvement projects
- Supports local inspection readiness in line with global PV strategy
- Identify issues and raise them to help Horizon be inspection ready and compliant.
- Archive documents per applicable internal standards and operating procedures
Qualifications and Skills Required:
- Support global medical review of pharmaceutical technical complaints and medical information inquiries were applicable
- Assist in MedDRA coding of medical terms for clinical study reports
- Support local PV relevant projects and document review
- Collaborate to monitor the Clinical Safety Operations electronic mailbox
Horizon Core Values & Competencies:
- Nursing or Pharmacy degree plus 3+ years of biotech/pharmaceutical experience in drug safety/Pharmacovigilance
- Clinical/medical research experience in biotech/pharmaceutical or clinical research organization
- Previous experience with adverse event reporting systems, FDA and EU drug safety/Pharmacovigilance requirements
- Proactive demeanor
- Excellent written and oral skills
- Proficient in Microsoft Office
- Professional demeanor.
- Self-starter attitude.
- Strong interpersonal skills.
- Excellent written and verbal communication skills.
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
- Drives Results
- Ensures Accountability
- Decision Quality
- Instills Trust
Horizon requires all U.S. employees to be fully vaccinated, as a condition of employment, with either Pfizer (fully approved by the U.S. Food and Drug Administration), Moderna or Johnson & Johnson (currently granted emergency-use authorization by the FDA). "Fully vaccinated" is defined as two weeks after your final dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Horizon will provide medical and religious accommodations as required by law.
Horizon Therapeutics plc does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.