Associate Director, Pharmacovigilance Scientist

Sumitomo Pharma • Marlborough, MA

2d

About The Position

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn. The Pharmacovigilance and Risk Management (PVRM) Associate Director serves as the PVRM point of contact for cross-functional, global development, and strategic partnership co-development teams while leading safety surveillance activities, including signal detection, evaluation, and risk management activities and ensuring adherence to safety governance for assigned compounds/products. This role will report to the Director, Pharmacovigilance and Risk Management (PVRM).

Requirements

• Proven ability to investigate and resolve complex safety-related issues and make/evaluate proposals for appropriate corrective action.
• Good understanding of global drug safety dynamics and experience with risk mitigation strategies preferred.
• Experience with FDA/EU and/or other regulatory agencies, preparing safety reports for health agencies and authorities both domestically and globally.
• Demonstrated skills working within a matrix environment.
• Ability to work collaboratively with others within and external to the company.
• Strong communication skills with excellent written and spoken English.
• Ability to work independently and productively and set priorities across multiple projects with little supervision.
• Excellent interpersonal skills with demonstrated ability to work in a multi-disciplinary setting and foster teamwork.
• Demonstrate coaching skills to develop the team as appropriate.
• Presentation skills.
• Minimum 8+ years of Pharmacovigilance and Risk Management experience required.

Nice To Haves

• Prior oncology industry experience preferred.
• Experience with early phase development preferred.
• Experience working on a fasted paced dynamic environment.
• Prior leadership or project management experience strongly preferred.

Responsibilities

• Supports Drug Safety Physician’s Safety Governance efforts by leading cross-functional Safety Management Team (SMT) assessing drug safety profiles and providing safety guidance and input to key safety documents, including IBs, ICFs, protocols, study reports, regulatory reports, and responses to regulatory requests.
• Leads/contributes to signal detection, monitoring, evaluation, interpretation, escalation, and appropriate communication of safety information through established safety governance.
• Maintains continuous monitoring and updates of safety profiles for assigned investigational and marketed products and ongoing risk/benefit assessment for investigational/marketed products.
• Serves as point of contact for and collaborates with colleagues from Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other related departments.
• Represent PVRM at cross-functional Steering Committee meetings or corporate partner-related meetings -Joint Safety Forums (JSFs) and PVC.
• Performs Review of adverse event reports, including but not limited to all serious events of interest, and expedited individual case safety reports, ensuring that appropriate interpretation, consistency, and quality are applied to adverse event case assessment on individual and aggregate levels.
• Generates or assists with input to Analysis of Similar Events, if required.
• Performs review of coding (e.g., reaction, suspect/concomitant product, indication, laboratory data, medical history).
• Provides support for investigator brochures, protocols, informed consent, final study reports, and other safety-relevant documents as appropriate.
• Leads early identification of safety issues that require Safety Governance escalation from Safety Management Teams (SMTs) to Therapeutic Area Safety Committees (TASCs) and/or the Executive Safety Committee (ESC).
• Serves as SMT Chair/Quorum member for assigned products.
• Serves as subject matter expert in study protocol design, review of interim reports for ongoing clinical trials, clinical study reports, safety summary documents, and responses to regulatory requests.
• Prepares and may present individual case safety report issues, aggregate data analyses and interpretation, strategies for submission documents such as the ISS and SCS, and proposed risk mitigation strategies for discussion at internal meetings.
• Provides input to key internal safety documents, including Risk Management documents (REMS, RMPs), development, and updates/maintenance of expectedness guides.
• Work collaboratively with PV and cross-functional team members to manage the benefit/risk profile of assigned products and ensure patient safety.
• Review Literature search strategy and perform literature monitoring (with vendor support) and ensure appropriate sources are incorporated into signal detection activities .
• Participate in aggregate safety report activities, including data compilation and analysis, as well as the writing of assigned sections (with vendor support).
• Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests.
• Serve as a subject matter expert in PVRM within the assigned program(s) as well as the larger SMPA organization (R&D and Commercial).
• Develop Standard Operating Procedures, Work Instructions, and other controlled documents.
• Contribute to internal departmental and/or cross-functional inspection readiness and operational improvement activities.
• Support collaboration with external partners.
• Supports PVRM or cross-functional ad-hoc projects or assignments that require safety input, ensures compliance with regulations/internal SOPs, and fosters a culture of “Patient First” in line with SMPA’s values and related behaviors.

Benefits

• opportunity for merit-based salary increases
• short incentive plan participation
• eligibility for our 401(k) plan
• medical, dental, vision, life and disability insurances
• leaves provided in line with your work state
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed