Manager, Drug Safety - Anywhere US

United States
11 Jun 2021
11 Jul 2021
R & D
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Manager, Drug Safety - Anywhere US

Office or remote based

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview

As the Manager, Drug Safety you will be providing management oversight as assigned to members of the Safety Project Management (SPM) team, the Safety Surveillance team, the Medical Coding team, the Argus administrators, and assigned Safety Management projects; and providing line management support to assigned departmental resources as needed. Responsibilities also include leadership of departmental initiatives and managing business development activities for potential new clients. A portion of his/her time is spent performing functional tasks as necessary.

  • Performs operational management responsibilities including hiring, performance management, training and mentoring, and professional development of staff.
  • Performs resourcing activities including assigning staff to projects, monitoring resource workloads, and assessing resource projections to ensure appropriate resources are available to meet corporate/client/project objectives while achieving optimal utilization of staff.
  • Liaises with other managers to ensure consistency of approach within the department and company.
  • Participates in bid and proposal development, attending and presenting at bid defense meetings.
  • Writes/reviews/updates Safety Management Standard Operating Procedures (SOPs) and Work Instructions (WI).
  • Participates in departmental initiatives, training, and implementation of process changes.
  • Supervisory responsibilities include but are not limited to providing technical and operational guidance and direction to direct line reports and colleagues, checking output of work, ensuring deliverables are met, and administering company policies including pay programs and performance management.
  • Provides status updates and proposed action plans to the department head regarding projects, staff, quality, and compliance issues.
  • May serve as the departmental representative regarding interactions with other functional areas.
  • Mentors and trains new Safety Project Managers and/or Safety Management staff as needed.
  • Participates in audit preparation and conduct of audits.
  • Performs and provides oversight for duties within the Safety database including developing, testing, and validating of client specific databases using specialized software; supporting the daily operation of the pharmacovigilance system and associated applications; performs and provides oversight for client specific migrations utilizing application import and export functionality; and provides technical support for application users.
  • Responsible for troubleshooting and resolving software or data related problems; developing validation documents, interfacing with clients to gather requirements and determining software solutions, and training end users as needed.

  • Bachelor's degree in nursing (B.S.N.), Registered Nurse (R.N.), Doctor of Pharmacy, Health Science degree or other related field of study required, and 8+ years Safety/ SPM / Safety database experience or equivalent combination of applicable industry experience, and the demonstrated ability to manage results in terms of costs, methods, and employees effectively.

  • In-depth know ledge of medical terminology and of GCP, ICH guidelines, global drug safety and drug development process, and other applicable country regulations.
  • Understanding of relevant company practices.
  • Intermediate proficiency in Microsoft Word, MS Project, Excel, PowerPoint, and Outlook.
  • Proficient in the use of safety databases or ability to learn safety database software and related software functionality.
  • Understanding of project budgets, including resourcing and budgeting software knowledge.
  • This position requires the ability to travel

This job excludes Colorado applicants.

If you're passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire. The Company will not sponsor applicants [to this position] for work visas.



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