Manager, PVRM

Job Overview

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).

Job Duties & Responsibilities

Benefit-Risk & Safety Surveillance

• 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 and ongoing safety surveillance activities.

Aggregate Safety Reporting

• Participate in and lead aggregate safety report activities, including data compilation, analysis, and writing of assigned sections, with vendor support as applicable.
• Ensure high-quality, accurate, and inspection-ready contributions to periodic and ad hoc safety reports.

Safety Governance & Cross-Functional Engagement

• Compile agendas, data, presentation materials, and meeting minutes in collaboration with the Program Safety Lead for cross-functional Safety Management Team (SMT) meetings.
• Represent PV Operations on cross-functional program and project teams and support PV Medical Safety activities as required.

Ad Hoc Safety Issues & Regulatory Interactions

• Coordinate responses to ad hoc safety issues and inquiries from regulatory authorities, clinical sites, or healthcare professionals in collaboration with PV physicians.
• Manage internal and cross-functional communications, data requests, and compilation of analyses and responses related to safety issues.

Inspection Readiness & Operational Excellence

• Contribute to departmental and cross-functional inspection readiness activities, audits, and health authority inspections.
• Support operational improvement initiatives and continuous process enhancements within PVRM and across functions.

Subject Matter Expertise & External Partnerships

• Serve as a subject matter expert in pharmacovigilance, including both operational and medical safety aspects, for assigned programs.
• Support collaboration and safety oversight activities with external partners and vendors, as applicable.

Knowledge, Skills and Abilities:

Scientific, Regulatory & Technical Knowledge

• 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, including contributing to signal evaluation, benefit-risk assessment, and identification of appropriate risk mitigation strategies.
• Solid understanding of global drug safety regulations and guidelines, including FDA, EMA/EU, ICH, GVP, and applicable local regulations; experience supporting preparation and review of safety reports and regulatory responses.
• Ability to critically interpret clinical, post-marketing, and literature safety data and apply sound scientific judgment in collaboration with Drug Safety Physicians and cross-functional partners.
• Knowledge of core pharmacovigilance processes, including signal detection, aggregate reporting, safety governance activities, and inspection readiness.

Collaboration & Matrix Effectiveness

• Demonstrated ability to work effectively in a matrix environment, collaborating with Clinical Development, Regulatory Affairs, Biostatistics, Data Management, Quality, and external partners.
• Strong interpersonal and teamwork skills with the ability to build productive working relationships across functions and organizations.
• Comfortable representing PVRM on cross-functional teams and contributing safety expertise to support program-level objectives.

Communication & Professional Skills

• Strong written and verbal communication skills with the ability to clearly convey scientific and safety-related information to diverse audiences.
• Capable of preparing and reviewing clear, concise, and inspection-ready safety documentation, presentations, and meeting materials.
• Demonstrates professionalism, sound judgment, and the ability to incorporate feedback and differing perspectives.

Execution, Problem-Solving & Personal Attributes

• Strong analytical, problem-solving, and critical-thinking skills, including the ability to manage evolving safety information and regulatory expectations.
• Highly organized and detail-oriented, with the ability to manage multiple tasks and priorities with minimal supervision.
• Ability to work independently while remaining aligned with team objectives and established processes.

Education & Experience Requirements:

• 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.

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 is involved. 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.

The base salary range for this role is

$127,900.00 - $159,900.00

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, in accordance with applicable law.

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.