Pharmacovigilance Associate
Job Title: Safety Surveillance Associate II The Safety Surveillance Associate II will design and implement trial-specific safety reporting processes under the direction of the Medical Monitor or Safety Surveillance Management. This role involves drafting and maintaining trial-specific reporting plans and creating educational materials for safety reporting. The associate will train trial personnel and relevant Safety Surveillance staff on processes, participate in the design and implementation of safety reporting databases, and coordinate safety reporting across multiple trials.
Responsibilities
- Design and implement trial-specific safety reporting processes.
- Define reporting criteria and associated processes.
- Draft and maintain trial-specific reporting plans and processes.
- Create educational materials for safety reporting.
- Train trial personnel and relevant Safety Surveillance personnel.
- Participate in the design, testing, and implementation of safety reporting databases.
- Coordinate trial-specific safety reporting processes across multiple trials.
- Ensure compliance with SOPs, FDA, NIH, and global regulations.
- Perform clinical review of serious adverse event forms and documentation.
- Communicate effectively with sites and trial personnel to obtain safety data.
- Create clinical narratives for Medical Monitor review.
- Enter and oversee data entry of safety data into appropriate databases.
- Perform audits of safety databases for data quality.
- Work closely with sponsor and trial personnel on safety data issues.
- Review trial-specific data listings and reports for quality and accuracy.
- Develop regulatory reports and documentation.
- Coordinate development of trial-specific safety data reconciliation processes.
- Provide updates and reporting to Safety Surveillance personnel and management.
- Mentor and train new Safety Surveillance personnel and other clinical research staff.
- Perform additional regulatory-related duties as needed.
Essential Skills
- Minimum of three years of clinical research experience.
- Experience in drug safety, case processing, pharmacovigilance, and regulatory affairs.
- Ability to write safety case narratives and process serious adverse event data.
- Experience in querying sites for complete SAE data and identifying missed SAEs.
- Understanding of FDA, NIH, and global regulations for Serious Adverse Event Reporting.
- Professional work ethic and experience communicating with sponsors.
Additional Skills & Qualifications
- Four-year degree in clinical research, life sciences, or healthcare-related field.
- Experience as a Registered Nurse, Pharmacist, or similar healthcare professional.
- Ability to work in a small team environment and incorporate feedback positively.
- Ability to process multiple SAEs per day.
Work Environment
This position is 100% remote. Candidates must reside in states where the organization is licensed to employ, including CA, DC, FL, GA, MD, NY, SC, TN, TX, VA, AZ, HI, IL, MT, CO, MS, NJ, PA. Job Type & Location This is a Contract position based out of Bridgewater, NJ. Pay And Benefits The pay range for this position is $46.67 - $48.00/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)
Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Jun 12, 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. 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