Principal Pharmacovigilance SME

About Our
Client:

Our client is a leading provider of Pharmacovigilance Technology
Solutions. They bring deep expertise in drug safety, paired with advanced
technology, including AI and GenAI. Their innovative solutions tackle the most
pressing challenges in the pharmaceutical industry. These solutions drive both
operational efficiency and enhanced business performance.

Their offerings include proprietary products for automated case intake,
advanced reporting platforms, GenAI -based solutions, and expert services such
as Business Transformation, Safety Systems Consulting (Argus, ArisG), Data
Migration, and Computer System Validation. These flexible and scalable
solutions are designed to meet the needs of both large global companies and
smaller organizations across diverse markets. With a focus on improving data
accuracy, optimizing workflows, and ensuring patient safety, their solutions
enable clients to address regulatory requirements while reducing operational
costs. By streamlining complex safety processes, they empower pharmaceutical
companies to drive lasting business value and maintain a competitive edge in a
rapidly evolving industry.

Position Overview:

·         Position: Principal / Associate Director / Solution Lead – Pharmacovigilance (PV)
SME

·         Location: East Coast, USA

·         Experience: 15+ years

Requirements

Key Roles and Responsibilities:

• Expertise in PV Business Processes and Safety Systems
  Configuration: Combine deep knowledge of Pharmacovigilance business processes with
  hands -on expertise in configuring PV systems (e.g., Oracle Argus Safety) to
  ensure that systems are aligned with both operational needs and regulatory
  requirements. Drive system configurations to optimize performance, data
  accuracy, and compliance.
   
• Requirements Gathering & Analysis: Collaborate with stakeholders to
  gather and analyze system requirements, ensuring tailored configurations that
  meet both business and regulatory demands.
   
• Knowledge of Global PV Regulations: Ensure compliance with regulations
  from major health authorities (e.g., MHRA, EMA, FDA, TGA, Health Canada, PMDA)
  through proper system configuration and governance.
   
• Governance & Oversight: Provide strategic guidance on safety
  system updates, driving alignment with evolving business goals and regulatory
  standards. Lead cross -functional teams in implementing system changes and
  ensuring ongoing compliance.
   
• Workflow Optimization: Continuously assess and improve system workflows to enhance efficiency
  and streamline operations in line with PV best practices.
   
• Regulatory Reporting: Oversee the development of key reports, such as Aggregate Reports, Signal
  Detection, and KPIs, ensuring compliance with global PV regulations.
   
• Technology Understanding: Possess a strong understanding of the technologies involved in
  Pharmacovigilance systems, particularly in relation to system configurations,
  data handling, and integration with other enterprise platforms. While not an
  expert -level requirement, the candidate should understand how these systems fit
  within the broader technology ecosystem of a PV organization.
   
• Data Migration: Have a foundational understanding of data migration processes related to
  safety systems, ensuring seamless transitions between systems and accurate data
  transfers. Provide insights into how data migration impacts the system configurations and business processes.
   
• BI Reporting & Analytics: Have a working knowledge of Business
  Intelligence (BI) reporting and analytics, ensuring that system configurations
  support effective reporting, including compliance and safety performance
  dashboards. Understand how BI tools are integrated with safety systems for
  real -time monitoring and reporting.
  

Behavioral
Skills:

• Stakeholder Engagement: Engage effectively with cross -functional teams, regulatory bodies, and
  external stakeholders to ensure alignment on system requirements. Leverage
  strong communication and negotiation skills to manage stakeholder expectations
  and align configurations with business goals.
  
  
• Adaptability: Quickly respond to changes in regulatory standards and business needs in
  a fast -paced environment. Demonstrate flexibility in adjusting to new
  challenges and evolving demands in the PV landscape.
  
  
• Leadership: Provide leadership in cross -functional projects, mentor junior team
  members, and support strategic decision -making. Guide teams through system
  implementations and improvements, ensuring alignment with business objectives.
  
  
• Critical Thinking: Apply strong analytical skills to solve complex configuration challenges
  while ensuring regulatory and business objectives are met. Proactively identify
  potential issues and develop solutions that maintain system integrity and
  compliance.
  

 
Ideal Candidate Profile:

The ideal candidate
will be an expert in Pharmacovigilance business processes and Safety Systems
configuration, with extensive experience in global PV regulations and
requirements analysis. They should also have a strong understanding of
technology, data migration, and BI reporting as they relate to PV systems, with
the ability to oversee end -to -end processes and ensure compliance. This role
offers opportunities for growth into senior leadership positions as the company
expands globally.

Why
Join Our Client:

Join a dynamic,
people -centric environment that values ownership and accountability. We offer a
nurturing culture that provides opportunities for growth and development,
recognizing your contributions based on merit. You will be part of a team with
decades of experience in life sciences, working on impactful projects that
shape the future of industry. Collaborate with innovative technologies, drive
change, and grow your career with us. Enjoy professional development,
leadership opportunities, and the chance to make a real difference in a
fast -evolving field.

Benefits