Senior Manager, Safety Agreements

Location
Tarrytown, New York, US
Posted
Aug 02, 2018
Ref
13891BR
Required Education
Other
Position Type
Full time
Position Summary

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.

Summary:

Responsible for coordinating the drafting and finalization of Safety Agreements (also known as Safety Data Exchange Agreements or SDEAs) with License Partners (LPs) and other external parties to ensure clarity, consistency and compliance with safety reporting requirements globally.
As the function evolves, may require management of direct report(s).

Duties:

• Work with other Regeneron functions (Business Development, Legal, etc.) and LP/other external parties to prepare and finalize SDEAs to meet study and other development/commercialization timelines. Ensure SDEAs terms are aligned with Regeneron's internal standards, and whenever feasible, aligned across LPs and/or projects.

• Track and maintain SDEAs to ensure their currency.

• Develop and maintain SDEA SOPs and templates

• Liaise with other PV functions to facilitate collaboration with LPs, vendors, and other Regeneron functions.

• Assist with relevant PV functions to set up and negotiate vendor contracts, and manage amendment in collaboration with Procurement and Finance. Monitor invoices to ensure timely and appropriate management; escalate issues as needed.

• Monitors updates to regulations that impact PV deliverables and require updating of Safety Agreements

• Assists with PV process improvement activities, whether internal or involving groups external to PV or Regeneron, including vendors or License Partners.

• Exercises independent judgment in managing deliverables and maintaining compliance with SOPs, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables.

• Effectively manages workload to ensure overall compliance with PV standards

• Authors new and updates to SOPs and Working Instructions, and conducts related training.

• When applicable, responsible for management of assigned personnel, which includes but is not limited to management of job performance, career development and training.

Requirements:

• Well informed on relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.

• Effective communication skills, both written and verbal

• Effective time management and priority setting to ensure on-time and high quality deliverables

• Demonstrated commitment to high standards for quality, integrity, and accountability.

• Experience with managing complex projects.

• Demonstrated success in working on cross-functional teams in a leadership role.

• Pharmacy, nursing or degree in healthcare and/or life sciences required, advanced degree preferred.

• Previous Pharmacovigilance/Drug Safety experience in pharmaceutical / biotech industry required; typically with 8 + years of Pharmacovigilance/Drug Safety experience.

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 Regeneron's 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.