Pharmacovigilance Specialist

Job Title: Pharmacovigilance Specialist – ICSR Processing & Quality Control

Duration: 12 Months

Location: Remote (EST preferred)

Pay Rate: $60/hour

Hours: 40 hours per week

Job Summary:

• We are seeking an experienced Pharmacovigilance Specialist to support clinical trial and post-market Individual Case Safety Report (ICSR) processing and quality control.
• The ideal candidate will have strong knowledge of pharmacovigilance regulations, safety database systems, medical terminology, and regulatory reporting requirements.

Key Responsibilities:

• Perform case triage, intake, data entry, and quality control of ICSRs from clinical trials and post-market sources.
• Prepare case narratives, perform MedDRA coding, draft follow-up queries, and communicate safety events to internal stakeholders.
• Conduct retrospective quality checks on processed cases to ensure accuracy and compliance.
• Manage assigned cases independently, ensuring timely completion and regulatory reporting.
• Reconcile discrepancies between clinical and safety databases in collaboration with Data Management teams.
• Investigate and document reasons for delayed regulatory reporting of clinical trial cases.
• Ensure compliance with applicable global and local pharmacovigilance regulations and guidelines.

Required Qualifications

• Bachelor’s degree in Science or a healthcare-related field.
• Minimum 4 years of experience in pharmacovigilance.
• Hands-on experience with ICSR processing using safety databases such as Argus, ArisG, or Veeva.
• Knowledge of global and local pharmacovigilance regulations, including FDA, ICH, and EU requirements.
• Experience with MedDRA coding, medical narrative writing, and case quality control.
• Strong understanding of medical terminology and clinical concepts.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

Work Environment

• Fully remote position, with preference for candidates who can work within Eastern Time (EST) hours.
• Must be able to manage assigned cases and meet deadlines, including weekends and holidays when required.

About Us:

Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU.

IntelliPro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at https://intelliprogroup.com.

Compensation:

The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility.