Vendor Case Management Specialist

Jul 17, 2017
Jul 19, 2017
Employer Type
Direct Employer
Employment Type
Full Time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Responsible for supporting Pharmacovigilance Operations in the successful management of vendor and case processing deliverables in accordance with applicable regulations. Primary responsibilities will include case processing activities like receipt and submission of reports from all investigational and marketed products to ensure timely processing of adverse events reports as described in the FDA Code of Federal Regulations, Regeneron Licensing Partners Safety Data Exchange Agreements and SOPs. Will be responsible for supporting Pharmacovigilance Operations compliance for the management of License Partner cases posted on a secured server and case reconciliation in accordance with Regeneron Licensing Partners Safety Data Exchange Agreements and SOPs. Interacts with PVRM personnel and applicable vendors during conduct of essential responsibilities. May Support case processing safety related activities like case finalization. May represent organization on specific projects.

  • Independently evaluates case reports from all sources and routes case reports to triage.
  • Independently monitors the safety database workflow state for approved cases that are ready for submission (FDA) / distribution (LP) and monitor E2B Gateway.
  • Generates the appropriate forms (CIOMS / MedWatch) as applicable and documents compliance within the Safety database
  • Independently monitors License Partner (LP) mailbox and manages CIOMS/cases to be posted on a secure server.
  • Completes monthly reconciliation of cases (including E2B when applicable) exchanged with LP
  • Identifies and proposes process improvements to improve efficiency of tasks performed on daily basis
  • May have to communicate directly with outside Vendors.
  • Individual demonstrates:
  • Independent judgment in problem-solving, and implementing decisions.
  • Ability to apply time-management skills for PV Ops deliverables.
  • Work is reviewed for soundness of judgment and overall adequacy and accuracy. Normally receives no instructions on routine work assignments but some instructions on project assignments.
  • Clearly articulates role/responsibilities and PV knowledge for inter- and intradepartmental meetings.
  • Knows when to escalate an issue and has the ability to apply critical thinking if timelines are at risk
  • Supports development and maintenance of SOPs and Work Instructions and applicable documentation specific to vendor management
  • Support PV Ops Sr. Specialist for daily case processing activities like case finalization
  • Support PV Ops Sr. Specialist in activities related to oversight of external vendor case processing deliverables
  • Bachelors level degree in life sciences required. Pharmacy, nursing or equivalent required, advanced degree preferred.
  • BS Degree with 5 -7 years of related experience or
  • MS with 3-5 years of related experience or advanced degree in Pharmacy (PharmD) or similar with previous exposure to industry (ex. participation in internships/fellowship programs).
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regenerons unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.