Director, Pharmacovigilance Intake and Regulatory Submissions

Role Summary

The Director, Pharmacovigilance Intake and Regulatory Submissions leads GPS department services in accordance with ICH-GCP guidelines, regulatory requirements and SOPs. The role oversees Intake of adverse event data and the subsequent reporting of ICSRs to health authorities, Alliance Partners, and internal destinations, ensuring compliant, complete and accurate safety information. It also leads a global team responsible for Intake and ICSR submissions across pre- and post-marketing activities and maintains reporting rules in the Argus safety database.

Responsibilities

• ICSR intake and submissions from all sources to all applicable destinations, leveraging data automation, validation, and analytics tools.
• Oversight of all aspects of Intake responsibilities for ICSRs, including vendor management.
• Oversight of ICSR submissions, including database configuration, study particulars assessment, and global regulatory reporting requirements; approve configuration requests.
• Provide input into contract deliverables to support outsourced Intake and Submissions activities and assist with review, execution, and implementation of related contracts.
• Oversee follow-up activities, including targeted follow questionnaires related to risk management plans and routine safety data monitoring obligations.
• Review or create metrics to measure intake and reporting compliance to regulatory agencies, Alliance Partners, internal destinations, and CROs.
• Train and mentor staff on safety information related to Intake and ICSR submission processes.
• Serve as ICSR Intake and Submission SME for audits and inspections.
• Develop and maintain best practices/processes for high-quality, compliant safety information management.
• Act as point of contact for queries from external or internal stakeholders.
• Perform other related duties as assigned per business needs.

Qualifications

• Independently identify, analyze, and problem-solve moderate to complex issues and trends.
• Strong knowledge of the clinical research process and global pharmacovigilance regulations, systems, and processes.
• Previous people management experience with ability to mentor and develop direct reports.
• Strong knowledge of intake and reporting platforms and systems (e.g., LifeSphere Advanced Intake, PVIT).
• Thorough understanding of global regulatory requirements and compliance with procedural documents and regulations.
• Excellent written and verbal communication skills; able to express complex ideas.
• Able to develop knowledge of protocol, regulatory requirements, and company SOPs.
• Able to identify and document regulatory non-compliance and related issues.
• Excellent organizational and interpersonal skills.
• Ability to reason independently to assess and propose solutions in a clinical setting.
• Attention to detail and ability to resolve discrepancies on compliance reports.
• Professionalism, customer service excellence, and positive representation of the company.
• Commitment, dedication, cooperation, adaptability and flexibility with changes in responsibilities.
• Honesty, integrity, and ability to work effectively with diverse people.
• Ability to establish and maintain effective relationships with internal and external customers and gain trust and respect.
• Ability to organize, plan, and execute projects, including delegation and guiding others to meet timelines and quality standards.

Education

• Bachelor's Degree in one of the life sciences or clinical research and/or a licensed healthcare professional required.
• Equivalent combination of relevant education and experience.

Additional Requirements

• Ability and willingness to travel domestically as required; ability to rent an automobile.