Manager, Pharmacovigilance Scientist

Sumitomo Pharma

5+ years

$154,000 to $192,500

Remote, USA

10 Oct. 2, 2024

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Sumitomo Pharma

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company headquartered in Japan, with significant operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.), and Europe (Sumitomo Pharma Switzerland GmbH). Our focus is on addressing patient needs across various therapeutic areas, including oncology, urology, women's health, rare diseases, psychiatry and neurology, as well as cell and gene therapies. With a diverse portfolio of marketed products and a robust pipeline of early- to late-stage assets, we are committed to accelerating the discovery, research, and development of innovative therapies to improve patient outcomes. For more information, please visit our website at Sumitomo Pharma America or follow us on LinkedIn.

Job Overview

We are seeking a dynamic, highly motivated, and experienced individual for the position of Manager, Pharmacovigilance Scientist. In this role, you will be instrumental in performing pharmacovigilance (PV) activities for assigned programs. Collaboration with cross-functional colleagues across the Sumitomo Pharma America organization—such as Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management, and Biostatistics—is essential.

Key Responsibilities

Collaborate with PV and cross-functional team members to manage the benefit-risk profile of assigned products and ensure patient safety.
Assist in signal detection activities, including data assembly, validation, and evaluation.
Perform literature monitoring (with vendor support) to incorporate relevant sources into signal detection activities.
Lead aggregate safety report activities, including data compilation, analysis, and writing of assigned sections (with vendor support).
Compile agenda, data, slides, and minutes for cross-functional Safety Management Team meetings in collaboration with the Program Safety Lead.
Represent PV Operations on cross-functional program teams and support PV Medical Safety activities as needed.
Coordinate responses to ad hoc safety issues, including communication with internal teams and the submission of data requests.
Contribute to departmental and cross-functional inspection readiness and operational improvement initiatives.
Serve as a subject matter expert in Pharmacovigilance within the assigned program and support collaboration with external partners.

Qualifications

Minimum of a bachelor's degree in a healthcare or life sciences field; a master's degree or other advanced degree is preferred.
At least 3 years of experience in Pharmacovigilance within the pharmaceutical industry; experience in oncology or neurology is strongly preferred.
Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products.
Ability to work independently and set priorities across multiple projects with minimal supervision.
Excellent interpersonal skills and a proven ability to foster teamwork in a multi-disciplinary setting.
Strong communication skills with proficiency in written and spoken English.

Compensation and Benefits

The base salary range for this role is $154,000 to $192,500, and is part of a comprehensive rewards package. This includes merit-based salary increases, short incentive plan participation, a 401(k) plan, medical, dental, vision, life and disability insurance, and generous time-off policies, including unlimited paid time off, 11 paid holidays, and additional leave during the last week of December.

Compliance and Confidentiality

All employees are expected to maintain compliance with applicable regulatory, legal, and operational rules, ensuring that activities are conducted with the highest ethical standards. Confidentiality of all information encountered during employment is paramount.

Equal Opportunity Employment

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, marital status, sex, gender, gender identity, sexual orientation, disability, veteran status, or any other characteristic protected by law.

For more information about EEO and the law, please visit the following pages: EEO.

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Manager, Pharmacovigilance Scientist

Job Description

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