United States onlyTheDirector, Pharmacovigilance 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.
#GDPSJobs
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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