This position will oversee and assist with pharmacoepidemiology and post-authorization risk management activities for assigned products.
- Leads the Epidemiology team and provides management oversight and direction to Epidemiologists
- Contributes to the design and implementation of safety-related post-marketing studies (PASS, observational studies, PMRs) including feasibility assessments, development of study designs and protocols, and communicates results to internal and external stakeholders
- Conducts research on natural history of disease to support safety surveillance and assessment
- Leads and conducts observational studies, including but not limited to real world data analysis and real-world evidence generation with collaboration of cross-functional stakeholders
- Contributes to benefit: risk analysis and discussions at safety governance meetings
- Contributes and authors responses to safety inquiries received from global regulatory agencies
- Participates in or may lead cross-functional teams to ensure timely deliverables and submission to health authorities as required
- Supports the development and implementation of of Risk Management Plans (RMP) and Risk Evaluation and Mitigation Strategies (REMS)
Qualifications and Skills Required:
- Advanced degree in epidemiology, pharmacoepidemiology, and/or related fields, PhD/DrPH preferred
- 7+ years of pharmaceutical or biotechnology experience of which 5+ years in a pharmacovigilance, pharmacoepidemiology, or safety risk management setting
- Experience with biostatistics
- Knowledge of regulations governing pharmacovigilance for human medicines
- Experience with PV databases and statistical data analyses of clinical data
- Must be able to work effectively as a team member in a highly interactive and collaborative environment
- Strong analytical and writing skills
- Experiences in risk management preferred
- Proficient in Microsoft Office.
- Professional, proactive demeanor.
- 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.