Description:

Essential Job Duties And Responsibilities

The Manager, Safety Data Analytics (SDA) is responsible for managing data analysis team within the global SDA group to ensure that requests for safety data are processed accurately and efficiently in compliance with our written guidelines and procedures, and meeting quality and timeliness standards. The Manager, SDA is responsible for development and support of relevant processes and methodologies, ensuring they are adopted supporting timely report generation, maintenance of data integrity and compliance. Define, track, and analyze performance metrics of their data analysis team that demonstrate adherence to quality and timeliness standards, and relevance of support provided to internal and external stakeholders.

• Oversee daily operational activities within the SDA group, including tracking of requests.
• Monitor and assess workload distribution.
• Partner with stakeholders to provide SDA coverage during IST hours, ensuring efficient collaboration, problem-solving, and decision-making across the global team.
• Provide support for Sr. Analyst/Scientist when engaging with requester and external SMEs to define requirements and strategy, as required.
• Provide support for project-related work
• Provide continuity of coverage in support of QPPV
• Represent SDA in cross-functional meetings as needed.
• Participate in recruitment of staff.
• Develop and manage PV Reports report generation performance metrics, overseeing optimization of report generation times, monitoring scheduled report generations and, identifying trends and solutions for improvement with escalation as appropriate.
• Develop and manage PV Reports report generation performance metrics, overseeing optimization of report generation times, monitoring scheduled report generations and, identifying trends and solutions for improvement with escalation as appropriate. Develop and execute complex database searches
• Collect and confirm request requirements working closely with internal and external stakeholders to confirm report parameters
• Support operational projects impacting GSDR and downstream integrations.
• Ensure appropriate escalation of issues to the leadership team.
• Contribute to for the development and implementation of team control documents.
• Support CAPA/QI resolution process for SDA, ensuring deliverables are met.
• Interface with internal and external stakeholders on SDA deliverables.
• Provide end of line review and approval for Audit and Inspection requests
• Participate and Lead cross-functional meetings that require SDA representation.
• Development Activities and other work
  
  

Qualifications:

Minimum Qualification

• Bachelor’s degree in computer science, data science, life science, or related discipline
• Previous pharmaceutical industry experience, specifically experience in pharmacovigilance typically demonstrated by a minimum of 8+ years of pharmaceutical experience.
• Previous experience in management role preferred.
• Experience with managing relationships with business partners and vendors.
• Strong working knowledge of relational databases required.
• Advanced knowledge of computer programming, specifically SQL.
• Strong understanding of Pharmacovigilance regulatory framework, e.g., GxP, ICH
• Strong understanding of Adverse Event processing
• Working knowledge of Pharmacovigilance systems and understanding of processes supported required.
• Strong project management and time management skills required.
• Demonstrated ability to streamline workflow activities, evaluate processes and work in an agile environment to improve efficiency, quality and compliance is required.
  
  

Other Requirements

• Excellent computer proficiency, e.g., MS Office
• Strong verbal and written communication skills required.
• Strong presentation skills to fit target audience and key stakeholders required (including senior leaders).
• Ability to influence without authority is required.
• Ability to work independently to investigate and resolve technical or data issues with attention to detail is required.
• Experience in hiring, retaining professional staff preferred.
• Strong analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.
• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude and strategic focus.
• Demonstrated experience leading projects preferred.