Sr. Manager, Global Patient Safety Standards and Training

Location
Tarrytown, New York, United States of America
Posted
Jul 26, 2021
Ref
25036BR
Required Education
Bachelors Degree
Position Type
Full time
Reporting to the Associate Director of Global Patient Safety (GPS) Standards and Training, this position is responsible to strategically establish and maintain procedures and policies to ensure consistency with regulatory requirements and industry standards, and to ensure training on those procedures and polices is conducted throughout the GPS department. Leads development and implementation of training as well as curriculums for GPS. Makes critical decisions on sophisticated to highly sophisticated issues regarding work approach for GPS procedural and training related tasks. Works independently across multiple areas. Receives general business direction, as needed. Possesses strong technical and project management skills. Supervises staff.
In this role, a typical day might include the following:

Develop, implement and maintain SOPs, work instructions, templates, forms, and business practice tools in collaboration with Process & Procedures group as well as subject matter experts (SMEs) within and outside GPS; this includes periodic review of procedures to ensure they continue to accurately describe GPS processes.

We need you to lead the GPS procedural portfolio to ensure the PV system aligns with global safety regulations for clinical trial and post marketing.

Drive standardization across GPS processes and training; support procedural document implementation.

Establish and run training curricula in collaboration with SMEs.

Build and maintain training materials with SME input/support as needed.

We expect you will deliver pharmacovigilance training to partners.

Handle AE training for employees, contractors and vendors.

Supervise training compliance for GPS and vendors providing safety services in partnership with GPS and other SMEs.

Archive procedural and training documentation including individuals' compliance with training.

Monitor GPS regulations globally for changes and collaborate with SMEs to update procedures when required.

Provide input on PV requirements (e.g., reporting, training, archiving records, etc.) for contracts.

Collaborate with and/or handle PV vendors with respect to procedural and training aspects to support GPS activities and results.

Lead initiatives and projects as requested to continuously improve the effectiveness and efficiency of GPS processes and training.

Collaborates with Global Development Training and Technical Training, when applicable, to ensure training requirements are implemented for assigned roles in procedures.

Coordinate the review cycles of assigned procedural documents and approval workflows.

We need you to manage corrective and preventative actions as assigned.

Provide support for audits and inspections as requested.
This role might be for you if:
  • Bachelor's degree in healthcare or life sciences; An advanced degree such as PharmD, RN or BSN is helpful.
  • Minimum 9+ years experience in a global Pharmacovigilance/Drug Safety department is required.
  • Minimum of 5+ years proven experience leading people.
  • Must have solid understanding of global Pharmacovigilance/Drug Safety regulations and PV Quality Management Systems.
  • Validated project management experience.
  • Must have experience handling vendors.
  • Consistent track record of forging relationships to promote collaboration and driving successful projects.
  • Ability to influence others.
  • Strong organizational skills and writing skills.
  • Excellent interpersonal skills (written and verbal) and ability to work with people in all levels of the organization and externally.
  • Strategic problem solver, ability to problem-solve and make decisions.
  • Self-motivated with the ability to work effectively and independently in a multifaceted environment with ambiguity
  • Must possess solid understanding of pharmacovigilance regulations and guidelines (EMA, MHRA, FDA, PMDA, ICH).
  • Advanced experience analyzing data in Excel (e.g., pivot tables) and utilizing PowerPoint is highly preferred.


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.