Pharmacovigilance Safety Operation Manager

Pharmacovigilance Safety Operation Manager

Join our team as a Pharmacovigilance Safety Operation Manager where you will play a crucial role in representing Patient Safety on the Study Management Team. This position involves interfacing with various stakeholders to ensure robust safety processes are maintained across assigned studies, managing the review and revision of safety language in study documents, and contributing to service provider oversight and the development of safety management plans.

Responsibilities

• Represent Patient Safety as a member of the Study Management Team.
• Interface with the Study Management Team, safety service providers, and medical safety reviewers.
• Assist with oversight of safety data case processing.
• Manage the review and revision of safety language in relevant study documents.
• Prepare and maintain safety management plans.
• Contribute to service provider oversight.
• Assess changes to informed consent form (ICF) safety information by sites and IRBs.
• Assist with the preparation and management of aggregate reports, such as the Development Safety Update Report.
• Prepare and contribute to written processes supporting pharmacovigilance activities.
• Assist in maintaining pharmacovigilance key performance indicators and metrics, focusing on expedited report submissions and investigator notifications.
• Monitor pharmacovigilance-related service provider compliance.
• Contribute to the safety assessment strategy and aggregate safety review.
• Provide pharmacovigilance-specific guidance for service provider audit planning.
• Assist with authoring pharmacovigilance standard operating procedures.
• Perform other activities as assigned.

Essential Skills

• Solid foundation in Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations.
• Ability to work independently and effectively in a remote-based, multifunctional team.
• Experience managing safety service providers.
• Experience reviewing cumulative safety data and ability to interpret, synthesize, and communicate complex clinical and pharmaceutical information.
• Experience in the preparation and authoring of aggregate safety reports.
• Thorough understanding of the drug development process and context applicable to safety surveillance activities.
• Ability to execute tasks and ensure completion and documentation.
• Excellent organizational skills for multitasking in a fast-paced environment with changing priorities.
• Excellent oral and written communication skills.

Additional Skills & Qualifications

• At least 5+ years' experience in pharmacovigilance and clinical development; oncology experience is preferred.
• Direct experience in a small biotech environment as well as large pharmaceutical experience is a significant advantage.
• Immuno-oncology therapeutic area experience or equivalent is required; CAR-T experience is preferred.
• Demonstrated experience managing pharmacovigilance service providers.

Work Environment

This position is remote-based, and candidates should be located in WA or CA to work during Pacific Standard Time (PST) hours.

Job Type & Location

This is a Contract position based out of Bothell, WA.

Pay and Benefits

The pay range for this position is $100.00 - $100.00/hr eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.