Sr Associate, PSPV Case Services
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.
- Performs quality control of global serious and non-serious adverse event case processing
- Oversees the integration of all source documentation into global PV including uploading and quality control checks of relevant files
- Supports local inspection readiness in line with global PV strategy and contributes to local PV related CAPA processes as requested
- Archives documents per applicable internal standards and operating procedures
- Provides adequate PV training of all local concerned HZN staff with global training materials
- Conducts effectiveness checks of intake received from call centers
- Supports global medical review of pharmaceutical technical complaints and medical information inquiries
- Provides oversight of global reconciliation between call centers (and other key service providers, as applicable) with Horizon case processing service provider
- Assists in MedDRA coding of medical terms for clinical study reports
- Supports local PV relevant projects and document review
- Creation and maintenance of Safety Management Plans for Clinical Trials
Qualifications and Skills Required:
- Nursing or Pharmacy degree plus 2+ 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.
Horizon Core Values & Competencies:
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
- Drives Results
- Ensures Accountability
- Decision Quality
- Instills Trust
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.