Temp - Global Patient Safety Regulatory Intelligence

Location
Basking Ridge, NJ, United States
Posted
May 06, 2021
Ref
24080BR
Required Education
Bachelors Degree
Position Type
Contract
Responsible for assisting the GPS Pharmacovigilance Regulatory Intelligence Lead with the identification, review and dissemination of new and updated regulatory information specific to pharmacovigilance. We expect you to demonstrate understanding of the implications and impact of regulatory changes on pharmacovigilance regulatory compliance.
In this role, a typical day might include the following:
  • Collaborate directly with Regulatory Affairs Intelligence counterparts and contracted regulatory information provider(s) to ensure availability & awareness of accurate and timely PV-specific regulatory requirements
  • Liaises with other Regeneron functions that require PV-focused regulatory intelligence support, such as Clinical, Medical Affairs, etc.
  • Collates regulatory intelligence reporting requirements from a variety of sources into a format for different GPS colleagues' awareness
  • Tracks pharmacovigilance regulatory intelligence information critical issues within GPS and follows up on outstanding items
  • Assists GPS Pharmacovigilance Regulatory Intelligence Lead with authoring and updating a catalog of regulatory reporting requirements (i.e., ICSR and Periodic reports to CAs and ECs) for the countries in which Regeneron is performing all types of organized data collection including;
  • clinical trials (including IIS and CUP/IPU programs)
  • post-marketing (eg. Market Research programs)
  • We expect you will exercise independent judgment in managing results and maintaining compliance with SOPs and applicable worldwide regulations to ensure timely and consistent results
  • Effectively manages workload to ensure overall compliance with GPS standards
  • When applicable, responsible for other assigned tasks delegated by the GPS Pharmacovigilance Regulatory Intelligence Lead
This role might be for you if:
  • Bachelor's degree in Pharmacy, Nursing or Healthcare/Life Sciences required, advanced degree preferred
  • In-depth understanding of global Pharmacovigilance regulatory requirements
  • 5+ years of Pharmacovigilance/Drug Safety experience in the Pharmaceutical Industry; 2-4 years with advanced degree.

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.