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Daiichi Sankyo US · 3 days ago

Associate Director, Signal Management, CSPV

Basking Ridge, NJ

Full-time

Onsite

Lead/Staff, Director/Executive

$151K/yr - $226K/yr

5+ years exp

Daiichi Sankyo Group is a global pharmaceutical company focused on innovative therapies, particularly in oncology and rare diseases. The Associate Director of Signal Management will lead strategic initiatives for signal detection and management processes across the global safety organization, ensuring regulatory compliance and fostering continuous improvement.

Health CareTherapeuticsWellness

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

This individual will be the main point of contact and support all signal management activities. They will lead the safety signal governance and develop, or update associated policies, charter and procedures, as applicable

On a daily basis provide total oversight on the processes relating to the conduct of signal detection via the appropriate tool(s)

Perform monitoring and tracking of the signal workflow to ensure compliance with procedural documents

When required, assist the product safety teams in the entering of key signal information into the appropriate tool. Advise teams on key milestones relating to the tracking of a particular signal(s) to ensure compliance with global Sops. Lead the maintenance of signal tool and support tasks of change control, training material update, and end user support or process enhancement. In collaboration with the signal management head, this individual will determine the necessity and validity of change requests and when required, perform user acceptance training

Ability to answer all queries relating to the signal detection tool as well as troubleshoot issues and promptly identifying solution(s) to ensure compliance

Develop and deliver ad-hoc and periodic trainings to build organizational capability on the entire signal management process consisting of detection, evaluation, and if applicable, proposed actions (e.g., changes to product information and/or other risk minimization measures) as a result of a validated signal

This individual will be able to provide subject matter expertise to the GPTs on the processes relating to signal detection, investigation, evaluation, and tracking as well as instruct teams on how to properly conduct high quality clinical evaluation of signals in the appropriate tool (e.g., disproportionality assessments)

This individual will ensure compliance with applicable domestic and international regulations and applicable ICH/GCP guidelines to ensure patient safety for company’s products

Provide oversight over compliance activities and fosters a culture that seeks to constantly enhance global regulatory compliance to meet signal evaluation timelines

Develop quality systems and procedures for the signaling activities to assure regulatory compliance and meet regulatory reporting timelines. Controls and assures the quality of the material content of any documents sent to regulatory authorities. Provides compliance metrics to management, as needed

Lead continuous improvement around development of new signal workflow/process, development of quality systems and tools, updates to templates and procedural documents (e.g. SOPs) as appropriate

Collaborate with cross-functional teams (e.g., Medical Safety, Regulatory Affairs, Epidemiology) to ensure benefit-risk integration to ensure signal, epidemiological data, and regulatory requirement synthesize into a coherent risk management strategy

Represents the CSPV department as subject matter expert in cross-functional teams or committees and external environments at a global and regional level as required

Support audit and inspection readiness activities as a subject matter expert. This individual will be accountable for maintaining a state of inspection readiness and in turn, act as key representer of DS in inspections/audits (presentations of signal process, coordination of document requests) throughout the year. Additionally, this individual will be the lead in support of all corrective action/preventative action (CAPA) or process improvements for signal management

Qualification

PharmacovigilanceSignal detectionGlobal PV regulationsSafety databasesSignal detection platformsContinuous improvementInspection readinessCollaboration

Required

Bachelor's Degree Health care background or life science degree/Bachelors required

4 or More Years 5-7 years of relevant experience in pharmacovigilance within the pharmaceutical industry required

4 or More Years At least 4 years of experience in PV signal detection required

1 or More Years 3 years of experience collaborating on global project teams required

Experience with safety databases and signal detection platforms required

Experience in global PV inspection and/or audits required

Strong knowledge of global PV regulations and signal detection methodologies required

Preferred

PharmD preferred

PhD preferred

Company

Daiichi Sankyo US

Glassdoor4.0

Daiichi Sankyo US is a pharmaceutical company delivering innovative research, solutions, and treatments to improve health.

Founded in 2005

Basking Ridge, New Jersey, USA

10001+ employees

https://daiichisankyo.us

H1B Sponsorship

Daiichi Sankyo US 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

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Trends of Total Sponsorships

2025 (32)

2024 (25)

2023 (19)

2022 (12)

2021 (7)

2020 (6)