Manager, PVRM

Job Overview

We are currently seeking a dynamic, highly motivated, experienced individual for the position of Pharmacovigilance Scientist to perform PV activities for assigned programs. Ability to work collaboratively with cross‑functional colleagues across the SMPA organization including Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential.

• Work collaboratively 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, signal validation, and signal evaluation.
• Perform literature monitoring with vendor support and ensure appropriate sources are incorporated into signal detection activities.
• Participate and lead aggregate safety report activities including data compilation, analysis, and writing of assigned sections with vendor support.
• Compile agenda, data, slides, and minutes in collaboration with Program Safety Lead for cross‑functional Safety Management Team meetings.
• Represent PV Operations on cross‑functional program and project teams; support PV Medical Safety activities on program and project teams as required.
• Coordinate responses to ad hoc safety issues such as regulatory authority, site, or healthcare professional requests, along with PV physician, including communication with internal and cross‑functional team members, submission of data requests, and compilation of analysis and results.
• Contribute to internal departmental and or cross‑functional inspection readiness and operational improvement activities.
• Collaborate with Clinical Development to interpret safety data from ongoing clinical trials.
• Serve as a subject matter expert in Pharmacovigilance, including operations and medical, within the assigned program.
• Support collaboration with external partners.

• Strong understanding of pharmacovigilance regulations and drug safety reporting requirements.
• Skills in signal detection, risk assessment, and safety data analysis.
• Proficiency with safety databases and software.
• Ability to evaluate and write case reports and prepare regulatory submissions.
• Analytical thinking and attention to detail.
• Communication skills for cross‑functional collaboration and regulatory interactions.
• Project management and organizational abilities.
• Ability to work effectively within teams.
• Experience using tools such as Argus, Oracle, MedDRA, Empirica, and Excel is highly valuable.

• Minimum bachelor’s degree in a health‑care/life science related field; master’s or other graduate degree preferred.
• Minimum 3 years’ experience within Pharmacovigilance 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.

The base salary range for this role is $127,920 to $159,900, with a total rewards package that includes merit‑based salary increases, a short incentive plan, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurance, and leaves in line with your work state. Our robust time‑off policy offers flexible paid time off, 11 paid holidays, additional time off for a shutdown period in the last week of December, and 80 hours of paid sick time upon hire and each year thereafter.

Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer. Qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital, domestic partnership or civil union status, sex, gender, affectional or sexual orientation, disability, veteran or military status, domestic violence victim status, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.