TEMP - Senior Manager, GPS CERM
The Senior Manager Case Management is responsible for proactively managing routine Vendor Management and Case Processing results and activities in accordance with applicable regulations and agreements.
In this role, a typical day might include the following:
- Serves as a primary point of contact with vendor for handling routine activities and addressing related issues
- Evaluates all adverse event reports received from the case processing vendor for accuracy and regulatory reporting. Monitors case finalization work stream and prepares reports for distribution.
- Identifies and leads process improvement activities whether internal to group or PVRM; or involving groups external to PVRM or Regeneron, including vendors or License Partners.
- Works effectively with external departments and License Partners on relevant PV deliverables (ex. works with Medical Affairs on post-marketing studies/programs).
- Exercises independent judgment in managing case processing PV deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables.
- May be responsible for management of assigned personnel.
- Effectively manages workload to ensure overall compliance with PVRM standards
- Takes initiative in the ongoing process improvement for quality and compliance
- Authors new and updates to SOPs and Working Instructions, and conduct related training.
- Responsible for management of assigned personnel.
- Manage and develop staff, including quality standards, adequacy of training, job performance/ contributions, work quality and career development.
This role might be for you if:
- Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
- Act as subject matter expert in case processing and as a resource on relevant FDA, EU and ICH guidelines, initiatives and regulations.
- Experience with and demonstrated success in working on cross-functional diverse teams required.
- Demonstrated leadership of projects or teams.
- Bachelor's Degree in life sciences required
- Pharmacy, nursing or equivalent required, advanced degree preferred.
Previous relevant experience in the pharmaceutical industry required; typically at least 8 years in drug safety/pharmacovigilance
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.