Sr Manager, Pharmacovigilance Scientist
Company: Horizon Therapeutics
Location: Vernon Hills
Posted on: May 11, 2022
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Job Description:
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.
Position Summary: 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 the department's contribution to 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, proactive 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 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.
Keywords: Horizon Therapeutics, Arlington Heights , Sr Manager, Pharmacovigilance Scientist, Executive , Vernon Hills, Illinois
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