Director, PV Enablement

Warren, OH - USA

Monthly Salary: $ 202000 - 336600

Posted on: 20 days ago

Vacancies: 1 Vacancy

Job Summary

Regenerons Global Patient Safety Organization is looking for a Director PV Enablement to join the team!!

In this role a typical day might include:

The Director of PV Enablement will report directly to the VP of Global Patient Safety (GPS) Operations. This role is pivotal in shaping the delivery of pharmacovigilance (PV) governance to ensure operational requirements are met within a growing global PV platform.
In coordination with the Vice President (VP) of GPS Operations provide strategic oversight and deliver global PV governance in partnership with the GPS Leadership Team (GPS LT).
Develop and maintain operational reporting dashboards and provide status oversight for key GPS project initiatives in collaboration with the VP of GPS Operations.
Partner with cross-functional teams including Development Operations Portfolio Management and Biostatistics/Data Management to establish operational portfolio forecasting for GPS.
Offer strategic holistic support for GPS interfaces to enable PV operations and ensure alignment across functions.
Lead operational excellence optimization activities including benchmarking PV innovation and capabilities as assigned.
Identify and assess operational risks across all areas of GPS ensuring proactive mitigation strategies are in place.

This role might be for you if you can/have:

This enablement role is accountable for demonstrating pharmacovigilance (PV) technical expertise and leadership working collaboratively with key stakeholders to perform the following essential functions:
Strategic PV Operations Oversight and Governance: In coordination with the Vice President (VP) of GPS Operations provide strategic oversight and ensure the effective delivery of global PV governance within the Global Patient Safety (GPS) organization and leadership team.
Operational Reporting and Forecasting: Implement an operational reporting dashboard and oversee the status of key GPS project initiatives by partnering with the VP of GPS Operations to ensure the effective delivery of portfolio requirements. Collaborate with cross-functional teamsincluding Development Operations Portfolio Management and Biostatistics/Data Managementto establish operational portfolio forecasting.
Support for GPS Interfaces: Offer strategic and holistic support to GPS interfaces to enable PV operational alignment and effectiveness.
Operational Excellence: Lead operational excellence initiatives including benchmarking PV innovation and capabilities as assigned. Holistically identify and assess GPS operational risks supporting inspection readiness in collaboration with team stakeholders and relevant areas.
Regulatory Compliance and Safety Initiatives: Ensure the successful execution of safety initiatives maintain regulatory compliance and drive continuous process improvements within the GPS organization.
Cross-Functional Collaboration: Act as a key liaison between the PV department and other functions including Regulatory Affairs Development Quality and Regeneron.
Resource Management and Operational Planning: Provide strategic oversight to develop and implement resource management plans focusing on efficiency of operational requirements within GPS.
Planning and Execution Improvement: Oversee and apply a systematic approach using structured methodologies to continuously improve planning processes and operational execution. Identify strategic priorities in partnership with the VP to optimize workflows maximize delivery efficiency and enhance overall effectiveness.
Operational Optimization and Broader Partnerships: Actively participate in operational optimization activities by collaborating with Regulatory Affairs Global Patient Safety Development Quality and Global Development teams.
Leadership and Team Development: Manage ambiguity and translate challenges into tangible outputs and opportunities for the department.
Contribute to an enriching team environment that supports GPS culture capability growth and team development both as a team member and individually in alignment with the values of the Regeneron Way.

To be considered for this opportunity you must have the following:

Minimum Bachelors Degree with 12 years of relevant PV planning and operations experience in the pharmaceutical area and specific industry experience in managing and providing oversight of operations within a global patient safety organization highly preferred.
Function as a subject matter expert in global pharmacovigilance for GPS operations and planning.
A proven ability to lead and develop a diverse remit in a constructive goal-oriented environment with continuous improvement and innovation mindset.
Demonstrated problem-solving with the ability to flex across different complexities business situations and cross functional partners of global patient safety
Success in effectively utilizing PV technical expertise along with communicating and influencing decisions with all levels of an organization and delivering high quality work.
Demonstrated ability and track-record to lead PV operational and planning initiatives with excellence including governance activities.

#GDPSJobs

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits which vary by the U.S. benefits may include health and wellness programs (including medical dental vision life and disability insurance) fitness centers 401(k) company match family support benefits equity awards annual bonuses paid time off and paid leaves (e.g. military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US please visit For other countries specific benefits please speak to your recruiter.
Please be advised that at Regeneron we believe we are most successful and work best when we are together. For that reason many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.

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 parental status gender identity gender reassignment military or veteran status or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.

Salary Range (annually)

$202000.00 - $336600.00

Required Experience:

Director

Regenerons Global Patient Safety Organization is looking for a Director PV Enablement to join the team!!In this role a typical day might include:The Director of PV Enablement will report directly to the VP of Global Patient Safety (GPS) Operations. This role is pivotal in shaping the delivery of pha...