Job Description

Job Overview

The Senior Manager, Pharmacovigilance Scientist serves as the primary Pharmacovigilance and Risk Management (PVRM) point of contact for cross-functional, global development, and strategic partnerships. This role leads evaluation and risk management activities, ensuring adherence to safety governance for assigned compounds and products.

Job Duties and Responsibilities

• Lead cross-functional Safety Management Team (SMT) meetings to assess drug safety policies, and provide safety guidance and input to key documents, including Investigator Brochures (IBs), informed consent forms (ICFs), 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.
• Maintain ongoing monitoring and updates of safety profiles for assigned investigational and marketed products, ensuring continuous benefit-risk assessment.
• Collaborate with colleagues in Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other departments. Represent PVRM in cross-functional Steering Committee meetings and at partner meetings including Joint Safety Forums (JSFs) and Pharmacovigilance Committee (PVC) meetings.
• Review adverse event reportsincluding serious casesensuring appropriate interpretation, consistency, and quality in both individual case and aggregate safety assessments; assist with Analysis of Similar Events as needed.
• Review clinical coding (e.g., reactions, suspect/concomitant products, indications, laboratory data, medical history) and support preparation of investigator brochures, protocols, informed consent documents, final study reports, and other relevant safety documents.
• Facilitate early identification of safety issues requiring escalation from the SMT to the Therapeutic Area Safety Committees (TASCs) or Executive Safety Committee (ESC). Serve as SMT Chair or Quorum member as assigned.
• Serve as a subject matter expert (SME) in study protocol design, review interim clinical trial reports, clinical study reports, safety summary documents, and responses to regulatory requests.
• Support preparation and presentation of individual case safety report issues; conduct aggregate data analyses and interpretation; develop strategies for submission documents (e.g., ISS, SCS); and propose risk mitigation strategies for internal discussions.
• Contribute to the development and maintenance of internal safety documents, including Risk Management plans (REMS, RMPs) and expectedness guides.
• Work collaboratively with pharmacovigilance and cross-functional team members to manage the benefit-risk profile of assigned products, ensuring patient safety.
• Review literature search strategies and literature monitoring (with vendor support) and ensure appropriate incorporation of sources into signal detection activities.
• Participate in aggregate safety report generation, including data compilation, analysis, and assigned section writing (with vendor support).
• Coordinate responses to ad hoc safety issues raised by regulatory authorities, sites, or healthcare professionals.
• Serve as a subject matter expert in PVRM for assigned programs and contribute expertise across R&D and Commercial functions at SMPA.
• Develop Standard Operating Procedures (SOPs), Work Instructions, and other controlled documents as requested.
• Contribute to departmental and cross-functional inspection readiness and operational improvement initiatives.
• Support PVRM or cross-functional ad hoc projects requiring safety input, ensure regulatory and SOP compliance, and foster a "Patient First" culture in alignment with SMPA values.

Key Core Competencies

• Strong understanding of global drug safety dynamics, with hands-on experience in risk mitigation strategies preferred.
• Experience preparing safety reports and submissions to FDA, EMA, and/or other regulatory authorities.
• Effective working skills in a cross-functional, matrixed environment.
• Collaborative mindset and ability to build relationships across organizational boundaries.
• Excellent verbal and written communication skills.
• Demonstrated ability to work independently, prioritize across multiple projects, and deliver with minimal supervision.

Education and Experience

• Minimum 47+ years of relevant pharmacovigilance or drug safety experience in the biotechnology or pharmaceutical industry; prior leadership or project management experience strongly preferred.

The base salary range for this role is $151,840 - $189,800. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes 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. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including 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 to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.

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

Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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.

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 or liability for 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.

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