Assoc. Director GPS, ICSR Submissions
This position is responsible for the reporting of adverse event data to health authorities, alliance partners and internal destinations in compliance with applicable global regulations and contractual obligations. This role will lead a global team responsible for all aspect of 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.
In this role, a typical day might include the following:
- Manages the internal submissions process for all destinations including regulatory authorities, alliance partners and internal departments
- Tracks and monitors all ICSR timelines to ensure that submissions to regulatory agencies, alliance partners, internal destinations and contract research organizations (CROs) are compliant with procedural requirements, regulatory requirements, and contractual obligations
- Ensures the accuracy and completeness of electronic and hard copy regulatory submissions
- Provides support during interactions with regulatory agencies reviewing submission content
- Contributes to process improvement initiatives across the organization
- Assists with other regulatory activities and special projects as required
- Support the investigations of non-compliance issues and identification of root cause for late ICSR submissions
- Manages appropriate corrective actions related to ICSR submission activities
- Actively manage the safety report scheduling, resources and timelines
- Track and maintain compliance with regulatory timelines and submission requirements
- Assess impact of new regulations on the safety database reporting rules and oversees updates as appropriate
- Participate in cross-functional meetings as SME in ICSR submissions
- Generate and use established reports to monitor daily case workload and reports due
- Contributes to development of standardized practices, procedures, metrics and measures productivity and performance within the submissions team
- Assist in the preparation of ICSR related health authority responses
- Provide management and oversight of ICSR E2B warnings and transmission failures
- Supports investigator alert notification process
This role might be for you if:
· Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
· Knows how/when to apply organizational policy or regulatory procedures to a variety of situations.
· Ability to work under pressure in order to meet tight timelines
· Able to work effectively in a matrix environment
· Strong attention to detail along with the ability to problem solve
· The ability to provide direction to a team, and to influence peers and team members appropriately preferred
· Excellent project management skills with the ability to align internal and external resources
· Demonstrated competence in obtaining, analyzing, disseminating, and reporting safety information in compliance with global regulations
· Degree preferred to be Bachelors of Science or related healthcare degree however may be waived for relevant experience
· Minimum of 5 years drug safety experience required
· Demonstrated proficiency in safety database functionality
Global Drug Safety Case processing experience
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.