The Adverse Event Intake Coordinator plays a critical role in ensuring the timely and accurate processing of adverse event reports related to our company's products. This position is responsible for receiving, reviewing, and processing incoming adverse event reports (AEs) from various sources, including healthcare professionals, consumers, and regulatory agencies. The ideal candidate is highly organized, detail-oriented, and possesses strong communication and problem-solving skills.

Key Responsibilities:

Case Intake Processing:

• Receive, review, and triage incoming AE reports from various sources.

• Creating, maintaining, and tracking case folders; filing, retrieving and distribution of case folders to operations team members.

• Perform ICSR surveillance on administrative topics and process including collection, reporting, follow-up processes.

• Accurately enter AE data into the company's safety database.

• Conduct initial case assessment and assign appropriate case status.

• Track and monitor the progress of AE investigations.

• Prepare case narratives and other relevant documentation.

• Assist with the preparation of safety reports for regulatory submissions.

Data Management & Quality Control:

• Assisting in maintenance of document control storage and relevant applications/systems as directed

• Providing key input to operations team on acquisition and/or upgrade of records management application/systems

• Ensure the accuracy and completeness of all AE data.

• Perform data entry and validation checks.

• Maintain accurate records and documentation.

• Support periodic audits and quality control checks on case processing activities.

Communication & Collaboration:

• Communicate effectively with internal and external stakeholders, including medical professionals, regulatory agencies, and other departments within the company.

• Collaborate with other team members to ensure timely and efficient case processing.

• Respond to inquiries and requests for information in a timely and professional manner.

Regulatory Compliance:

• Ensure compliance with all relevant regulatory requirements, including Good Pharmacovigilance Practices (GVP) and local regulations.

• Stay informed of any changes to relevant regulations and guidelines.

Process Improvement:

• Identify and implement process improvements to enhance the efficiency and accuracy of AE intake processes.

• Participate in team meetings and contribute to the development of best practices.

Qualifications:

Education: Bachelor's degree in a life science field (e.g., biology, pharmacy, nursing) or equivalent experience.
Fluent local language skills & excellent command of the English language
Experience: 1 year of experience in pharmacovigilance or a related field preferred.
Skills:

• Strong attention to detail and accuracy

• Excellent organizational and time-management skills

• Proficiency in Microsoft Office Suite (Word, Excel, Outlook)

• Strong written and verbal communication skills

• Ability to work independently and as part of a team

• Excellent problem-solving and analytical skills

Preferred Qualifications:

• Experience with electronic data capture (EDC) systems

• Knowledge of medical terminology and coding systems (e.g., MedDRA)

• Experience with regulatory submissions

#LI-REMOTE

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com