Pharmacovigilance Safety Operation Manager

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.
• Achieve and maintain pharmacovigilance key performance indicators and metrics, focusing on expedited report submissions and investigator notifications.
• Maintain pharmacovigilance-related service provider compliance.
• Contribute to the safety assessment strategy and aggregate safety review.
• Provide pharmacovigilance-specific guidance for service provider audit planning.
• 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.
• Immunooncology 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.

Requirements

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)

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.