Manager, PVRM

Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S., Canada and Europe focused on oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. With several marketed products and a diverse pipeline of early- to late-stage assets, we accelerate discovery, research and development to bring novel therapies to patients sooner.

We are seeking a dynamic, highly motivated, and experienced Pharmacovigilance Scientist to perform PV activities for assigned programs. Ability to work collaboratively with cross‑functional colleagues across the 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 in and lead aggregate safety report activities, including data compilation and analysis and writing of assigned sections.

• Compile agenda, data, slides and minutes in collaboration with the 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 these teams, as required.

• Coordinate responses to ad‑hoc safety issues such as regulatory authority, site or health‑care 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 Argus, Oracle, MedDRA, Empirica and Excel is highly valuable.

• Minimum bachelor’s level degree in a health‑care/life science related field; master’s or other graduate degree preferred.

• Minimum 3 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.

The base salary range for this role is $127,920 to $159,900. Base salary is part of our total rewards package which also includes merit‑based increases, short incentive plan participation, 401(k) eligibility, medical, dental, vision, life and disability insurances and leaves in accordance with state law. Total compensation, including base salary to be offered, will depend on candidate experience, skills, education and other factors permitted by law.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not an exhaustive list of all responsibilities, duties, and skills required.

All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.

Achieve and maintain…