Director/Sr Medical Director, Pharmacovigilance

Company: Horizon Therapeutics plc
Location: Lake Forest
Posted on: September 12, 2020

Job Description:

Director/Sr Medical Director, Pharmacovigilance Lake Forest, IL

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.

Responsibilities:

Lead the development and execution of translational, product-specific safety surveillance plans

Review, interpret and summarize safety data for specific deliverables (periodic reports, risk management plans, protocols, SAP, IB, IC, CSR, CTD)

Provide oversight, review and assessment of individual case safety reports and other patient-level safety data taking into consideration translational safety information

Present data and analyses to multiple internal/external stakeholder groups

Collaborate cross functionally on development teams, safety management teams and the safety review board

Maintain in depth knowledge of evolving global clinical development and pharmacovigilance regulations, methodologies and technologies

Develop and mentor staff.

Qualifications and Skills Required:

MD or DO. Board Certified/Board Eligible or equivalent

For senior medical director-level candidates, 5+ years’ experience in the pharmaceutical industry and at least 5+ years focused on clinical safety/pharmacovigilance

Expertise in global pharmacovigilance and clinical safety regulations and guidelines

Ability to objectively interpret, analyze and communicate medical and scientific data

Experience with drug safety databases (queries, reporting, visualization tools) and MedDRA coding

Strong written and verbal communication skills

Ability to cultivate and maintain collaborative relationships

Proficient in Microsoft Office

High degree of professionalism

Strong interpersonal skills

Excellent written and verbal communication skills

Horizon Core Values & Competencies:

Growth

Manages Ambiguity

Strategic Mindset

Demonstrates Self-awareness

Develops Talent

Accountability

Drives Results

Ensures Accountability

Decision Quality

Transparency

Courage

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.

Posted 30+ Days Ago

Full time

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About Us Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit follow us @HorizonNews  on Twitter, like us on Facebook  or explore career opportunities on LinkedIn .

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Keywords: Horizon Therapeutics plc, Lake Forest , Director/Sr Medical Director, Pharmacovigilance, Other , Lake Forest, California