Senior Manager, Pharmacovigilance Scientist
Company: Horizon Pharma
Location: Deerfield
Posted on: June 8, 2021
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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 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. The Person: This role requires good judgment and strong initiative. You need
to have the ability to effectively prioritise and manage a
diversified workload, often to strict deadlines. You should have
strong interpersonal skills, a professional approach with excellent
written and verbal communication skills. 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.
Keywords: Horizon Pharma, Arlington Heights , Senior Manager, Pharmacovigilance Scientist, Other , Deerfield, Illinois
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