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System One Services Associate Director Drug Safety Operations in Bothell, Washington

Associate Director Drug Safety OperationsBothell, Washington



Category:Scientific & Clinical

Job ID:157905

Date Posted:11/10/2020

Associate Director Drug Safety Operations

Contract Length: 6 mos


The Associate Director, Drug Safety Operations is responsible for operational management and leadership of case processing activities. The role is responsible for managing Case Coordination, Management, and Submission activities within Drug Safety Operations to ensure all ICSR processing comply with regulatory requirements and corporate and departmental procedures. This position requires the ability to influence and lead a diverse team, ensure strong partnership with internal and external partners and with senior management. The incumbent is accountable to compliance with all applicable local and international regulations and company Standard Operating Procedures.


• Provides subject matter expertise to Global Safety Operations (GSO) regarding ICSR processing and related regulations, systems, procedures and deliverables

• Oversight and personnel management across GSO Case Management, including goal setting, Manager performance evaluation assessments, and mentoring/career development

• Provide subject matter expertise on safety operations and overall data quality during audits/inspections as required

• Ensure timely submission of expedited safety reports and other external submissions through effective vendor (SMP) management and performance metrics review

• Lead and/or provide functional support for the maintenance and continuous improvement of internal and external case processing (e.g., quality evaluations and metrics)

• Effectively manages interactions with CROs and ensure highest quality of deliverables

• Provide functional support to other GSRM and GSO functions to ensure robust processes conducive to seamless case management activities and deliverables. Provide input as required to business requirements, vendor selection, contract details, vendor oversight /safety management plans (SMP), Pharmacovigilance Agreements (PVAs); review and approve governing documents, such as SOPs, Work Instructions / Training Guides and ensure seamless operational implementation

• Foster strong professional relations with other functions, e.g. Data Management, Biometrics, Quality Assurance, Regulatory, and others to optimally collaborate as a team

• Provide oversight and/or functional support for the Drug Safety Database System Owner.

• Other responsibilities as required


• Minimum of 5 years in Drug Safety / Pharmacovigilance in biotech or pharmaceutical industry setting, working with CROs, vendors, and business partner relationship management

• Experience with leading a large team (at least 15)

• Successful leadership experience in global pharmacovigilance operations with pre-and post-approved products

• Experience with selection and working with contract service providers for case processing and aggregate reporting activities

• Experience working in standard safety databases, preferably Argus

• Experience with regulatory inspections and company audits including FDA and MHRA/EMA PV inspections as related to Case Management activities

• Demonstrated experience working with cross functional areas with effective negotiation skills

• Excellent management and interpersonal skills


• BS Nursing, PharmD or other related healthcare background