Manager, PVRM

Sumitomo Pharma•Marlborough, MA

16h•Remote

About The Position

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).

Requirements

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.
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.
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.
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.
Minimum of bachelor’s level degree in a health care/life science related ہے.
Minimum 4 years experience within Pharmacovigilance and in the pharmaceutical industry.
Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and marketed products.

Nice To Haves

Master’s or other graduate degree preferred.
Prior experience in oncology, and/or neurology is strongly preferred.

Responsibilities

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.
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.
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.
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.
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.
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.