Sr Manager, Pharmacovigilance Scientist
- Employer
- Horizon Therapeutics
- Location
- Lake Forest, IL, United States
- Start date
- Nov 12, 2019
View more
- Discipline
- Science/R&D, Biotechnology
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioMidwest
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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.
The Senior Manager, Pharmacovigilance Scientist is responsible for managing and tracking of safety science deliverables to internal and external customers.
Responsibilities:
Qualifications and Skills Required:
Horizon Core Values & Competencies:
Growth
Accountability
Transparency
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.
The Senior Manager, Pharmacovigilance Scientist is responsible for managing and tracking of safety science deliverables to internal and external customers.
Responsibilities:
- Manages and tracks the production of periodic safety reports (PADER, PBRER, DSUR) and annual reports (NDA Annual Report and IND Annual Report)
- Manages and tracks the safety surveillance strategies for the company's development and marketed products
- Manages the identification, prioritization, and assessment of safety signals
- Manages and tracks the production of risk management plans for the company's marketed products
- Manages and tracks ad hoc safety analyses in response to health authority, DSMB, and Ethics Committee/IRB queries
- Manages, tracks, and makes updates to safety management plans for company-sponsored studies
- Assists with the development of safety sections of study protocols, clinical study reports, investigator brochures, and other related clinical documents
- Manages and tracks other safety science deliverables to internal and external customers
- Participates in cross-functional teams as a PV representative
Qualifications and Skills Required:
- Bachelor's degree or equivalent (health professional degree preferred)
- 5+ years of pharmaceutical or biotechnology experience of which 3+ years in a pharmacovigilance setting
- Previous experience with safety databases (Argus, ARISg, or equivalent)
- Knowledge and understanding of pharmacovigilance regulations for both marketed and investigational products
- Proficient in Microsoft Office.
- Professional demeanor.
- Strong interpersonal skills.
- Excellent written and verbal communication skills.
Horizon Core Values & Competencies:
Growth
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
Accountability
- Drives Results
- Ensures Accountability
- Decision Quality
Transparency
- Courage
- Collaboration
- 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.
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