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Sr Manager/Manager Drug Safety and Pharmacovigilance Systems

Cambridge, Massachusetts

Post Date: 10/13/2017 Job ID: 1707 Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety

The Manager of Drug Safety and Pharmacovigilance (DSPV) Systems is a member of the DSPV core team and is responsible for the use, maintenance and business function operational support of the externally hosted Safety Database (Oracle Argus Safety) and related systems.

In this role, the manager will create custom and ad hoc reports, develop and maintain user guides, training materials user support and SOPs, provide validation coordination and maintain the change control processes with the vendor as well as with internal change management processes.  The manager will need to drive the implementation of further system and analytical tools and reports for enhanced functionality with DSPV as well as cross-functionally. This role will work in close collaboration with DSPV, Quality Assurance Validation and IT, and as the business representative for further projects, define user requirements and acceptance testing as needed. 

Job Responsibilities:
  • Lead the design and implementation of Safety system and/or applications/system tools to sustain Drug Safety objectives, including Argus Safety, MedDRA, Analytics, Mart and Reporting tools, etc.  Coordinates with vendor creation of validation/testing documentation.  Executes as appropriate UAT testing.  Ensure proper storage of related documentation regarding any system update bases upon the initial requirements and any subsequent changes.    
  • Application administrator residing within the DSPV function, responsible for managing the implementation of all change control updates to Argus and related systems/tools.  Maintains configuration baseline documentation as appropriate. 
  • Translates requests for data outputs into programmed output table(s), listings, metrics, KPIs,
  • Create programming, validation methodology for the generation of reports for various data analysis (e.g. adhoc, periodic line listings, etc.).
  • Implement system change controls with external host vendor. 
  • Interpret regulatory guidance changes as they impact technology and provide technology expertise to implement system changes for maintaining compliance.
  • Coordinate medical dictionary version management and upgrades with system host vendor. 
  • Maintain compliance with relevant policies and procedures
  • Provide technology expertise for the definition and implementation of change initiatives aligned with vision and strategies.  Expertise in vendor procurement process (e.g. RFP) for DSPV related projects. 
  • Support the resolution of complex, cross-functional issues using strong problem solving abilities.
  • Inspect and resolve safety database problems quickly and effectively.  Escalate to vendor(s) as appropriate. 


Qualifications/ Requirements:
  • MS in technical field preferred; BS in technical field required
  • Minimum 5 - 7 years of experience within a regulated industry required with experience with validated pharmaceutical/drug safety systems and applications preferred
  • Ability to build and sustain relationships with internal/external partners and vendors
  • High-level understanding of global guidance, best practice and regulations supporting pharmacovigilance for post-marketing and investigative drugs
  • Understanding of MedDRA structure preferred
  • Advanced knowledge of Oracle databases and PLSQL programming
  • Advanced skills in report generation using business intelligence tools (Business Objects, SpotFire, Cognos, etc.)
  • Understanding of database architecture (Argus Safety Database preferred)

Skills/Knowledge Preferred:
  • High level of proficiency with MS Office applications
  • Knowledge of scientific terms and medical terminology
  • Quality orientation: attention to detail, accuracy
  • Understanding of documentation requirements (GxP) in a regulated environment
  • Advanced knowledge of controlled document applications preferred
  • Excellent written and oral communication skills Strong presentation, facilitation, negotiation, collaboration and communication ability.
  • Team player; open minded, creative thinker.  Capable of working effectively under pressure in a multi-cultural environment, at any level of the organization, with a variety of stakeholders
  • Contribute in maintaining an effective, open and supportive environment for the discussion of Drug Safety systems and application opportunities.

Kathleen Hepburn, SPHR
Senior Recruiter

Kathleen has been providing Human Resources and Recruiting solutions to a wide range of organizations for over 20 years. Her areas of expertise include talent sourcing and acquisition, HR planning, employee relations, and performance management. She is credited with developing strategic partnerships to quickly identify and recruit talent; leading corporate initiatives to grow revenues and reduce expenditures; and creating effective programs to train, retain and reward employees.
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