Associate Director, PVCM

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 providing oversight of pharmacovigilance operations in the successful management of vendor and case processing deliverables in accordance with applicable regulations and agreements.
Responsible for ensuring that assigned staff are appropriately prepared to support current and anticipated activities for receipt, processing, distribution/ submission of reports from global development programs and globally marketed products.
Responsible for ensuring inspection readiness; monitoring quality of PVRM deliverables; and monitoring compliance with case submission timelines as per regulatory requirements and agreements with License Partners and other parties. Incumbent may have a central role in audits and health authority inspections

Responsibilities:

1. Responsible for accurate and timely case processing deliverables.
2. Assist in development and execution of strategy that supports ability of staff to meet current and anticipated activities worldwide.
3. Thorough understanding of activities and issues facing staff. Skillful management and resolution of issues, which may, depending on complexity, require effective escalation.
4. Assume a supporting role in interactions with auditors and Health Authority inspectors. Assume a central role in responding to audit / inspection findings
5. Responsible for mentorship and active support of assigned staff.
6. Responsible for ensuring staff deliverables and interests are communicated to senior management, internal partners, and external partners in a timely manner. Keeping senior management apprised of status and issues on groups' activities/ projects.
7. Ensure compliance with all regulations, guidelines, guidances and Regeneron SOPs and Working Instructions governing pharmacovigilance.

Leadership responsibility for direct/indirect reports, with active oversight and support of their activities
Manage workload and support staff in meeting compliance objectives, optimizing job performance/ contributions, and achieving high levels of work quality.

Requirements:

Pharmacy, nursing or equivalent required, advanced degree preferred.

Previous Pharmacovigilance/Drug Safety experience in pharmaceutical / biotech industry required; typically with 9 + years (7 + years if Master's Degree) of Pharmacovigilance/Drug Safety experience.

Demonstrated successful management and completion of a Phase III/IV program(s) and leadership on projects of equivalent complexity.

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

• Experience with managing and supervising teams on complex projects. Demonstrated success in working on cross-functional teams

• Contributes to and manages organizational projects and goals to support their timely completion.

• Assist group members with their activities, as needed. Generally accomplishes tasks through Individual Contributors or other managers.

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.