Job Title: Pharmacovigilance Specialist

Job Description

Assist with the overall Clinical Safety and PSS operations associated with products, including the entire adverse events process, which may include safety data collected from clinical trials and/or post-marketing settings. Manage and process expendable adverse events to the required standard and submit them to the client and regulatory agencies within the agreed timelines. Provide high-quality service to both internal and external clients in a safe and cost-effective manner.

Responsibilities

• Manage the receipt and processing of all adverse event reports from any source or clinical trial.
• Enter safety data onto adverse event databases and tracking systems.
• Review adverse events for completeness, accuracy, and appropriateness for expedited reporting.
• Write patient narratives and code adverse events accurately using MedDRA.
• Determine listedness against the appropriate label for marketed products, if applicable.
• Identify and ensure the collection of clinically significant information missing from reports.
• Ensure swift and appropriate processing of cases requiring expedited reporting to regulatory agencies and other parties within required timelines.
• Report endpoints to clients, regulatory authorities, ethics committees, investigators, and other stakeholders within study-specified timelines.
• Submit expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, and other stakeholders within study-specified timelines.
• Perform database reconciliation with Data Management team or sponsor as needed.
• Process and review Expedited Safety Reports (ESRs) and Periodic Safety Reports (PSRs).
• Set up and maintain project files and documentation.
• Assist with the reporting of ESRs and PSRs to clients, regulatory authorities, ethics committees, investigators, and other stakeholders within study-specified timelines.
• Maintain a strong understanding of safety database conventions.
• Perform quality reviews or peer reviews of processed reports and support line management with trends and actions needed.
• Participate in signal detection, trend, and pattern recognition activities.
• Assist in preparing listings for Annual IND reports, Periodic Reports like PSURs, and Development Safety Update Reports.
• Generate monthly status and other project-specific reports, ensuring quality and accuracy of metrics and data.
• Support, train, and mentor less experienced safety staff in all aspects of case handling and adverse event reporting.
• Assist in reviewing cumulative safety data for submission to Drug Safety Monitoring Boards, regulatory authorities, or clients, and coordinate endpoint committees.

Additional Skills & Qualifications

• BS/BA 1-2 years of Safety experience or 2-3 years of relevant experience.
• MS/MA 1-2 years of Safety experience or 2 years of relevant experience.
• PharmD 1-2 years of Safety experience or 2 years of relevant experience.
• For PharmD, a one-year residency or fellowship can be considered as relevant experience.
• Degree preferred in Biological Sciences, Pharmacy, Nursing, Medical Sciences, Life Sciences, or related areas.
• Experience in the pharmaceutical, biotechnology, or CRO industry in related areas such as Medical Affairs, Clinical Data Entry and Management, Clinical Data Monitoring, Regulatory Affairs, or Quality Assurance.

Work Environment

Office environment with a hybrid work arrangement of 3-4 days in the office. Travel up to 5% of the time, including overnight stays as necessary, consistent with project needs and office location

Pay and Benefits

The pay range for this position is $36.00 - $50.00/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 hybrid position in Durham,NC.

Application Deadline

This position is anticipated to close on Mar 14, 2025.

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $36 - $50