Pharmacovigilance Specialist

ACTalent; EE. UU.; A distancia; USD 28.000 - 40.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Time Off / PTO

Descripción de la vacante

Actalent is seeking an Adverse Event and Product Complaint Reporting Specialist to manage AE and product complaint reporting using a patient management system, ensuring accuracy through quality checks and collaboration with clinicians.

You will perform data entry, coordinate with biopharma clients, and support clinical auditors by identifying trends and ensuring timely, compliant reporting.

Formación

• Bachelor's degree or commensurate experience preferred.
• Pharmacy technician or other clinical experience preferred.
• Oncology experience is a plus.
• Comfort working with patient management systems and clinical documentation.
• Ability to support clinical auditors by recognizing trends and issues in adverse event reporting.

Responsabilidades

• Create and submit adverse event and product complaint reports using data documented in the patient management system.
• Conduct thorough quality checks of all reports, including verifying spelling, drug manufacturer information, and grammar within clinical notes.
• Communicate with clinicians to address questions or concerns about reporting content or quality.
• Identify missing adverse events and product complaints through daily quality control processes and report findings to clinicians.
• Maintain and submit weekly and monthly reconciliation reports to biopharma clients per contract.

Conocimientos

Excel

Data entry

Attention to detail

Time management

Communication

Cross-functional collaboration

Multitasking

Healthcare experience

Customer service

Typing

Educación

Bachelor's degree or commensurate experience

Herramientas

Excel

Descripción del empleo

Job Title: Adverse Event and Product Complaint Reporting Specialist

Job Description

This role focuses on creating, submitting, and reconciling adverse event and product complaint reports based on data documented in a patient management system. The specialist ensures the accuracy and quality of all reports through detailed quality checks, collaborates closely with clinicians to resolve questions or concerns, and supports clinical auditors in identifying trends or issues in adverse event reporting.

Responsibilities

• Create and submit adverse event and product complaint reports using data documented in the patient management system.
• Conduct thorough quality checks of all reports, including verifying spelling, drug manufacturer information, and grammar within clinical notes.
• Communicate proactively with clinicians to address questions or concerns about the content or quality of adverse event and product complaint reporting.
• Identify missing adverse events and product complaints through daily quality control processes and promptly report these findings to clinicians.
• Ensure that any identified missing adverse event or product complaint reports are submitted, tracked, and fully accounted for.
• Maintain and submit weekly and monthly reconciliation reports to biopharma clients in accordance with contractual requirements.
• Assist clinical auditors in identifying trends, patterns, or issues in adverse event and product complaint reporting.
• Support continuous improvement of reporting processes by providing feedback and observations from daily quality control activities.
• Perform other related duties as assigned to support clinical operations and reporting accuracy.

Essential Skills

• Strong customer service orientation with the ability to work effectively with clinicians and other stakeholders.
• Proficiency with Excel spreadsheets, including moderate to advanced computer skills.
• Excellent written and verbal communication skills to prepare clear, accurate, and professional reports.
• Excellent organizational and time management skills to manage multiple reports, deadlines, and reconciliation schedules.
• Ability to multitask and prioritize work in a fast-paced environment.
• Demonstrated ability to work effectively with people across different functions and levels.
• High level of conscientiousness with exceptional attention to detail in data entry and report review.
• Flexibility and adaptability to changing processes, priorities, and client requirements.
• Ability to type rapidly and accurately, including both numerical and text data.
• Experience or familiarity with oncology, pharmacy, or clinical environments.
• Customer service experience in a healthcare or related setting.

Additional Skills & Qualifications

• Bachelors degree or commensurate experience preferred.
• Prior experience working in a pharmacy setting preferred.
• Oncology experience is a plus.
• Pharmacy technician or other clinical experience preferred.
• Comfort working with patient management systems and clinical documentation.
• Ability to support clinical auditors by recognizing trends and issues in adverse event reporting.
• Strong problem-solving skills and the ability to identify gaps or inconsistencies in data.
• Commitment to maintaining accurate, compliant, and timely reporting for biopharma clients.

Work Environment

The role is office-based and centers on working with patient management systems, clinical documentation, and Excel spreadsheets to manage adverse event and product complaint reporting. The specialist spends significant time performing detailed data entry, reviewing reports for accuracy, and communicating with clinicians via electronic and verbal channels. The environment requires sustained focus, strong organization, and comfort using computers and standard office software, while collaborating with clinical and auditing teams to meet reporting and reconciliation deadlines.

Job Type & Location

This is a Contract position based out of Cary, NC.

Pay and Benefits

The pay range for this position is $25.00 - $25.00/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 jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)

Job Type & Location

This is a Contract position based out of Cary, NC.

Application Deadline

This position is anticipated to close on Nov 20, 2026.

Workplace Type

This is a fully remote position.

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 withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

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

San Francisco Fair Chance Ordinance:

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

Massachusetts Lie Detector:

It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall 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 applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.