[Hiring] Manager, PVRM @Sumitomo Pharma America, Inc.

Role Description

The Safety Scientist Manager is responsible for providing pharmacovigilance and risk management support for assigned products across their lifecycle. This role works collaboratively with Pharmacovigilance (PV), Medical Safety, and cross‑functional stakeholders to manage the benefit‑risk profile of products, ensure patient safety, and support regulatory compliance. The position contributes to signal detection, aggregate safety reporting, safety governance forums, and inspection readiness activities, while serving as a subject matter expert within the assigned program(s).

Qualifications

• Minimum of bachelor’s level degree in a health care/life science related field
• Master’s or other graduate degree preferred
• Minimum 4 years experience within Pharmacovigilance and in the pharmaceutical industry
• Prior experience in oncology, and/or neurology is strongly preferred
• Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products

Requirements

• Strong working knowledge of pharmacovigilance and risk management principles across the product lifecycle, from early development through post‑marketing
• Demonstrated ability to investigate, assess, and resolve safety‑related issues
• Solid understanding of global drug safety regulations and guidelines, including FDA, EMA/EU, ICH, GVP, and applicable local regulations
• Ability to critically interpret clinical, post‑marketing, and literature safety data
• Knowledge of core pharmacovigilance processes, including signal detection, aggregate reporting, safety governance activities, and inspection readiness
• Demonstrated ability to work effectively in a matrix environment
• Strong interpersonal and teamwork skills
• Strong written and verbal communication skills
• Strong analytical, problem‑solving, and critical‑thinking skills
• Highly organized and detail‑oriented
• Ability to work independently while remaining aligned with team objectives

Benefits

• Base salary range: $127,900.00 - $159,900.00
• Opportunity for merit-based salary increases
• Short incentive plan participation
• Eligibility for 401(k) plan
• Medical, dental, vision, life and disability insurances
• Flexible paid time off
• 11 paid holidays plus additional time off for a shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter

Travel Requirements

• Primarily remote role with periodic on-site meetings in office
• Must be able to travel domestically and internationally as needed

Mental/Physical Requirements

• Fast-paced environment handling multiple demands
• Must be able to exercise appropriate judgment as necessary
• Requires a high level of initiative and independence
• Excellent written and oral communication skills required
• Requires ability to use a personal computer for extended periods of time