Senior Manager, PVRM Safety Scientist

Sumitomo Pharma•Marlborough, MA

4d•Remote

About The Position

The Senior Manager, Pharmacovigilance Scientist serves as a primary Pharmacovigilance and Risk Management (PVRM) point of contact for assigned programs. The role works collaboratively with cross-functional colleagues, global development teams, and strategic partners to lead and support safety evaluation and risk management activities and ensure appropriate application of safety governance processes for assigned compounds and products. The position supports ongoing safety-profile monitoring and benefit-risk evaluation for investigational and marketed products, including signal detection and assessment, review of adverse event reports, aggregate safety analyses, and regulatory submissions and responses. It serves as a PVRM subject matter expert for assigned programs and contributes safety expertise across R&D and Commercial functions. The role is primarily remote, with periodic on-site meetings, and requires domestic and international travel as needed. The role requires at least a bachelor’s degree in a healthcare, life science, or related scientific field and at least six years of relevant pharmacovigilance, drug safety, or related pharmaceutical/biotechnology industry experience. The base salary range is $157,000 to $196,300. The total rewards package includes merit-based salary increases, short incentive plan participation, 401(k) eligibility, insurance coverage, leaves, and paid time off.

Requirements

Bachelor’s degree or higher in a healthcare, life science, or related scientific field.
At least 6 years of relevant pharmacovigilance, drug safety, or related pharmaceutical/biotechnology industry experience.
Strong understanding of pharmacovigilance, drug safety, benefit-risk assessment, and global safety requirements.
Demonstrated experience with signal detection, evaluation, and safety data analysis.
Experience preparing and/or contributing to aggregate safety reports, regulatory submissions, and responses to regulatory authorities, including FDA and EMA and/or other global health authorities.
Ability to interpret clinical and safety data and communicate safety findings clearly to cross-functional stakeholders.
Ability to work effectively in a cross-functional and matrixed environment and build relationships across organizational and geographic boundaries.
Excellent written and verbal communication skills.
Ability to work independently, manage multiple priorities, and deliver high-quality work with minimal supervision.
Demonstrated leadership and project-management capabilities.
Comprehensive understanding of applicable FDA and EU pharmacovigilance requirements and GCP/GVP/ICH safety guidelines for investigational and marketed products.
Ability to travel domestically and internationally as needed.
Ability to use a personal computer for extended periods; work in a fast-paced environment handling multiple demands; and exercise appropriate judgment, initiative, and independence.

Nice To Haves

Advanced degree.
Relevant experience in clinical development safety, signal management, aggregate reporting, and/or benefit-risk assessment.
Prior experience leading cross-functional activities, programs, or projects.
Prior experience in oncology and/or neurology.

Responsibilities

Lead cross-functional Safety Management Team (SMT) meetings and provide safety guidance and input on key documents, including Investigator Brochures, informed consent forms, protocols, study reports, regulatory reports, and regulatory responses.
Contribute to signal detection, monitoring, evaluation, interpretation, escalation, and communication of safety information through established safety governance processes.
Monitor and assess safety profiles for assigned investigational and marketed products, supporting continuous benefit-risk evaluation.
Collaborate with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other functions; represent PVRM on cross-functional teams and partner safety meetings, including Joint Safety Forums and Pharmacovigilance Committee meetings, as applicable.
Review adverse event reports, including serious cases, to support appropriate interpretation, consistency, and quality across individual case and aggregate safety assessments; support Analysis of Similar Events as needed.
Review relevant clinical coding, including reactions, suspect and concomitant products, indications, laboratory data, and medical history; support preparation and review of safety-related clinical and regulatory documents.
Facilitate early identification and escalation of safety issues through established safety governance processes; serve as SMT Chair or Quorum member as assigned.
Review study protocols, interim clinical trial reports, clinical study reports, safety summary documents, and responses to regulatory requests as a PVRM subject matter expert.
Support preparation and presentation of individual case safety issues; conduct aggregate safety data analyses and interpretation; contribute to submission documents, including ISS and SCS; and support risk-mitigation strategy development.
Contribute to development and maintenance of safety and risk-management documents, including Risk Management Plans, Risk Evaluation and Mitigation Strategies, and expectedness guides, as applicable.
Collaborate with PVRM and cross-functional team members to manage product benefit-risk profiles and support patient safety.
Review literature search strategies and monitoring activities with vendor support and incorporate relevant information into signal detection and evaluation activities.
Participate in and lead assigned aggregate safety report activities, including data compilation, analysis, interpretation, and preparation or review of assigned sections, with vendor support as applicable.
Coordinate responses to ad hoc safety issues and requests from regulatory authorities, study sites, healthcare professionals, and other stakeholders with appropriate medical and cross-functional colleagues.
Serve as a PVRM subject matter expert for assigned programs and contribute expertise across R&D and Commercial functions.
Develop or contribute to Standard Operating Procedures, Work Instructions, and other controlled PVRM documents, as assigned.
Contribute to departmental and cross-functional inspection readiness, quality, compliance, and operational improvement initiatives.
Support PVRM and cross-functional projects requiring safety input, promote compliance with applicable regulatory requirements and internal procedures, and foster a Patient First culture consistent with SMPA values.