Director, Patient Safety Intake and Regulatory Submissions

The Director, Patient Safety Intake and Regulatory Submissions delivers Global Patient Safety (GPS) Department services according to ICH-GCP guidelines, regulatory requirements and Regeneron standard operating procedures (SOPs) and/or project specific procedures. This position is responsible for the oversight of the processes and systems which enable initial Intake of adverse event data (i.e., via electronic database capture (EDC), phone line, etc.), the subsequent reporting of Individual Case Safety Reports (ICSRs) to health authorities, Alliance Partners and internal destinations in compliance with applicable global regulations (ICH-GCP) and contractual obligations, and follow up activities to ensure receipt complete and accurate safety information. This role will lead a global team responsible for all aspects of Intake and ICSR submissions for the company product portfolio covering pre and post marketing activities. This position will also be responsible for the oversight and maintenance of all reporting rules in the global safety database, Argus.

In this role, a typical day might include:

• ICSR Intake and Submissions from all sources to all applicable destinations. This includes, but is not limited to expert knowledge of tools and systems that allow for data automation, advanced data validation, and analytics

• Oversight of all aspects of Intake responsibilities for ICSRs, including management of applicable vendors.

• Oversight of all aspects of ICSR submission including database configuration and assessment of study particulars and reporting requirements across current global regulations and approval of configuration requests

• Provides input into contract deliverables to support outsourced Intake and Submissions activities as well as assist with the review, execution, and implementation of related contract deliverables

• Oversight of the all follow up activities including but not limited to the issuance of targeted follow questionnaires associated with risk management plans or other routine safety data monitoring measures and obigations

• Review and/or creation of metrics to measure intake and reporting compliance to regulatory agencies, Alliance Partners, internal destinations and contract research organizations

• Training and mentoring of staff on safety information pertaining to Intake and ICSR submission processes

• Serve as ICSR Intake and Submission subject matter expert (SME) for audits and inspections

• Ability to further develop and maintain best practices/processes for high quality and compliant

• Point of contact for queries from external or internal stake holders.

• Performs other related duties as assigned or requested per business needs.

This role might be for you if you can/have:

• Independently identify, analyze, and problem solve moderate to complex issues and trends.

• Strong knowledge of clinical research process and global pharmacovigilance regulations, systems, and processes.

• Previous people management experience with the ability to mentor and develop direct reports.

• Strong knowledge of intake and reporting platforms, tools, and systems (i.e. LifeSphere Advanced Intake, PVIT, etc.)

• Thorough understanding of the global regulatory requirements and the importance of 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 any related issues.

• Excellent organizational and interpersonal skills.

• Ability to reason independently to assess and recommend specific solutions in a clinical setting.

• Attention to detail; able to identify and resolve discrepancies on compliance reports.

• Demonstrates professionalism and presents a positive image of the company.

• Demonstrates excellence in customer service, both internally and externally.

• Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.

• Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people.

• Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect.

• Ability to organize, plan and execute projects, including the ability to delegate and guide the work of others to achieve project completion timelines and quality standards.

To be considered for this opportunity, you must have the following:

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

• Minimum of 12 years of experience in safety and safety reporting.

• Equivalent combination of relevant education and experience.

• Computer literacy and experience working with Microsoft Office (Word, Excel, PowerPoint) required

• Excellent knowledge of Argus and its applications.

• Excellent verbal and written communication skills required.

• Excellent interpersonal and organizational skills required.

• Ability to work independently, prioritize effectively and work in a matrix team environment required.

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

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