Drug Safety Associate II

Job Title: Drug Safety Associate II Job Description The Drug Safety Associate II provides expert support in drug safety and pharmacovigilance, with a primary focus on the accurate and timely documentation of serious adverse events (SAEs) and other safety data. This role manages end-to-end case processing in the Argus Safety Database, ensures compliance with global clinical safety regulations and internal procedures, and contributes to the high-quality utilization of safety data across clinical and post-marketing programs. Responsibilities

- Process and assess serious adverse events (SAEs) from initial receipt through case closure in the Argus Safety Database, ensuring complete and compliant documentation.
- Perform end-to-end pharmacovigilance case processing, including case intake, medical assessment, coding, narrative writing, follow-up activities, expedited reporting, and quality control review for both clinical trial and post-marketing safety cases.
- Generate queries and draft clear, medically sound case narratives and adverse event summaries to support robust safety evaluations.
- Apply accurate and consistent coding of SAEs and AEs as reported in source documents, using established coding conventions to ensure standardized data categorization.
- Contribute to the development and revision of coding conventions to support consistent and high-quality safety data across studies and products.
- Define and apply a high standard of case quality review, ensuring sound medical safety data documentation in collaboration with the Drug Safety Physician.
- Schedule and manage submissions of expedited safety reports in Argus in accordance with regulatory timelines and internal procedures.
- Collaborate closely with cross-functional departments such as Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management to ensure appropriate collection, reconciliation, and handling of safety data.
- Support continuous improvement of drug safety case processing workflows and procedures to enhance efficiency, quality, and regulatory compliance.
- Perform additional drug safety and pharmacovigilance duties as assigned to support departmental goals and regulatory commitments.

Essential Skills

- Minimum 3 years of recent, hands-on experience with the Argus Safety Database, including end-to-end pharmacovigilance case processing, case management, and quality control review.
- Demonstrated end-to-end pharmacovigilance case processing experience covering case intake, assessment, coding, narrative writing, follow-up, expedited reporting, and QC review for clinical and post-marketing cases.
- Minimum 5 years of pharmacovigilance experience within a biotech, pharmaceutical, or contract research organization (CRO) environment.
- Strong understanding of global clinical safety and pharmacovigilance regulations and guidelines.
- Proficiency in medical documentation, including clear and accurate narrative and adverse event summary writing.
- Ability to perform detailed case quality reviews and ensure complete, accurate, and compliant safety case documentation.
- Experience collaborating with cross-functional teams involved in clinical development, operations, data management, regulatory affairs, and project management.
- Bachelor’s degree (BS/BA) in a related discipline with at least 5 years of related industry experience, or a master’s degree (MS/MA) in a related discipline with at least 3 years of related experience, or a PhD in a related discipline.
- Alternatively, BS or MS in Nursing, Pharmacy, or another clinical degree with a minimum of 3–5 years of clinical experience.

Additional Skills & Qualifications

- Experience in drug safety and pharmacovigilance, with experience handling both clinical trial and post-marketing safety data.
- Familiarity with safety databases and case processing workflows, particularly Argus.
- Ability to interpret medical and clinical information from source documents and translate it into structured safety case data.
- Strong attention to detail and commitment to data accuracy and regulatory compliance.
- Effective written and verbal communication skills for cross-functional collaboration.
- Organizational skills to manage multiple cases, timelines, and expedited reporting requirements.
- Comfort working in a regulated environment with established standard operating procedures and quality standards.

Work Environment This is a remote position based on Pacific Time (PST) hours. The role operates in a structured, compliance-driven pharmacovigilance environment, working extensively with the Argus Safety Database and other clinical and regulatory systems. Collaboration with cross-functional teams occurs virtually, requiring reliable connectivity and the ability to work effectively in a remote setting while aligning with PST business hours.
Job Type & Location
This is a Contract position based out of Alameda, CA.
Pay and Benefits
The pay range for this position is $38.00 - $46.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. 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.
Application Deadline
This position is anticipated to close on Sep 25, 2026. 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.

The company is an equal opportunity employer and will consider all applications without
regard to race, sex, age, color, religion, national origin, veteran status, disability,
sexual orientation, gender identity, genetic information or any characteristic protected
by law.

If you would like to request a reasonable accommodation, such as the modification or
adjustment of the job application process or interviewing process due to a disability,
please email [email protected] for other accommodation options.

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.

Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a
condition of employment or continued employment. An employer who violates this law
shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):
We may use Artificial Intelligence (AI) to support parts of our hiring process,
including sourcing, screening, and evaluating candidates. AI helps assess applications
and qualifications, but final decisions are made by our hiring team. By applying, you
acknowledge and agree that your application may be reviewed using AI tools.