Manager, Pharmacovigilance Scientist

2+ years

$154,000 to $192,500 per year

Remote, USA

10 Oct. 3, 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

Company Overview

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company headquartered in Japan, with key 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 in areas such as oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With a diverse portfolio of marketed products across these regions and a robust pipeline of early to late-stage assets, we leverage advanced technology capabilities to accelerate the discovery, research, and development of novel therapies. For more information about SMPA, visit our website here 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 essential in executing pharmacovigilance (PV) activities for assigned programs. Collaboration with cross-functional colleagues across SMPA—including Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management, and Biostatistics—is crucial.

Key Responsibilities

Collaborate with PV and cross-functional teams to manage the benefit/risk profile of assigned products, ensuring patient safety.
Assist in signal detection activities, including data assembly, validation, and evaluation.
Conduct literature monitoring (with vendor support) and integrate appropriate sources into signal detection efforts.
Lead aggregate safety report activities, including data compilation, analysis, and writing assigned sections (with vendor support).
Compile agendas, data, slides, and minutes in coordination with the Program Safety Lead for cross-functional Safety Management Team meetings.
Represent PV Operations on cross-functional program and project teams, supporting PV Medical Safety activities as needed.
Coordinate responses to ad hoc safety inquiries from regulatory authorities, sites, or healthcare professionals, in collaboration with PV physicians.
Contribute to internal departmental and cross-functional inspection readiness and operational improvement initiatives.
Serve as a subject matter expert in pharmacovigilance operations and medical aspects within the assigned program.
Support collaboration with external partners.

Core Competencies

Ability to work independently and efficiently, setting priorities across multiple projects with minimal supervision.
Excellent interpersonal skills, with a demonstrated ability to foster teamwork in a multi-disciplinary environment.
Strong communication skills, both written and verbal, with proficiency in English.

Education and Experience

Bachelor’s degree in a healthcare or life sciences field; a Master’s degree or terminal degree (MD, PhD, or PharmD) is preferred.
Minimum of 3 years of experience in pharmacovigilance within the pharmaceutical industry.
Experience in oncology and/or neurology is strongly preferred.
Comprehensive understanding of FDA and EU regulations and GCP/GVP/ICH safety guidelines for investigational and marketed products.

Compensation and Benefits

The base salary range for this role is $154,000 to $192,500. This salary is part of a comprehensive rewards package, including opportunities for merit-based salary increases, participation in a short incentive plan, eligibility for our 401(k) plan, and various health benefits. Our generous time-off policy includes unlimited paid time off, 11 paid holidays, additional time off during the last week of December, and 80 hours of paid sick leave annually.

Disclaimer

The above statements are intended to describe the general nature and level of work performed by individuals assigned to this position. They are not exhaustive and may be subject to change. All employees may be required to perform duties outside of their normal responsibilities as needed.

Confidential Data

All information (written, verbal, electronic, etc.) encountered by employees is considered confidential.

Compliance

Employees must achieve and maintain compliance with all applicable regulatory, legal, and operational rules and procedures, ensuring that all activities for and on behalf of Sumitomo Pharma America (SMPA) and its affiliates adhere to best industry practices and the highest ethical standards.

Mental/Physical Requirements

The role operates in a fast-paced environment, requiring the ability to manage multiple demands effectively. Employees must exercise appropriate judgment and demonstrate a high level of initiative and independence. Excellent communication skills are essential, and the ability to use a personal computer for extended periods is required.

Equal Employment Opportunity

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, religion, national origin, age, sex, gender identity or expression, 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:

Equal Employment Opportunity is THE LAW
EEO is the Law Poster Supplement

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