Associate Director, Signal Management, CSPV

Join a Legacy of Innovation 125 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.   

Job Summary:

This is a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily strategic initiatives to standardize, optimize, and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best practices, foster a culture of continuous improvement in benefit-risk evaluation, and participate in inspection readiness activities.
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.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education:

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

• PharmD preferred

• PhD preferred

Experience:

• 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

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Salary Range:

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