Sumitomo Pharma America, Inc. · 22 hours ago
Associate Director, Pharmacovigilance Scientist
United States
Full-time
Remote
Senior Level, Lead/Staff, Director/Executive
$155K/yr - $194K/yr
8+ years expSumitomo Pharma America, Inc. is a global pharmaceutical company focused on addressing patient needs in various health sectors. The Associate Director, Pharmacovigilance Scientist will lead safety surveillance activities and serve as the point of contact for cross-functional teams, ensuring adherence to safety governance for assigned products.
Pharmaceuticals
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
Qualification
Required
Minimum 8+ years of Pharmacovigilance and Risk Management experience required
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
Preferred
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
Benefits
Merit-based salary increases
Short incentive plan participation
Eligibility for our 401(k) plan
Medical, dental, vision, life and disability insurances
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
Company
Sumitomo Pharma America, Inc.
Sumitomo Pharma America (SMPA) is a science-based, technology-driven biopharmaceutical company focused on delivering therapeutic and scientific breakthroughs in areas of critical patient need in oncology, urology, women’s health, rare disease, cell and gene therapies and CNS.
Founded in 2023Marlborough, Massachusetts, US
1001-5000 employeesH1B Sponsorship
Sumitomo Pharma America, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (8)
2024 (9)
2023 (14)
Funding
Current Stage
Late StageLeadership Team
Adele Gulfo
Chief Executive Officer, Biopharma Commercial
Myrtle Potter
President and Chief Executive Officer, Sumitomo Pharma America
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