Assume significant role in RM activities working on outstanding and sophisticated assignments including performing signal management activities; responding to regulatory agency queries; preparing periodic safety documents (PSURs, RMPs, etc). Your work approach will require complex to highly complex decisions to be made to effectively complete tasks. May assume role of Lead for assigned compounds.Monitor the safety profile of assigned compounds to identify safety signals, and develop and execute a plan for their evaluation.Author regulatory documents for assigned compoundsPrepare and deliver presentations at SMT meetings; participate in Dose Escalation meetingsLeads other risk management activities as appropriate for assigned compounds.May represent Opth and ID Therapeutic Area for assigned compounds on cross-functional teams, including Regeneron Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external to RegeneronActively participate in the development and maintenance of SOPs and supporting documents.
In this role, a typical day might include the following:
While working independently with minimal support from Therapeutic Area Head:
7. Guide process improvement activities within GPS.
This role might be for you if:
We expect you to apply FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments. Ability to utilize GPS safety system database for purposes of medical case review and simple queries. Ability to effectively communicate (verbal and written) safety findings. Exceptional initiative, creativity and innovation skills with an advanced in-depth and broad knowledge base in field.
Previous safety or relevant clinical experience in the pharmaceutical industry required. We typically seek at least 7 years of risk management or relevant clinical experience in pharmaceutical/ biotech industry or health authority.
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.See More
Valid through: 2/10/2021