MI Ops Specialist 1

Highly motivated and detail-oriented Adverse Event Case Intake Processor to join our growing Pharmacovigilance team. In this critical role, you will be responsible for the accurate and timely intake, processing, and tracking of adverse event reports received from various sources. You will play a vital role in ensuring the safety of our products by diligently adhering to regulatory guidelines, internal Standard Operating Procedures (SOPs), and global best practices.

Key Responsibilities may include, but are not limited to:

Case Intake & Processing:

• Receive and process adverse event reports from various sources, including emails, faxes, phone calls, and databases.

• Conduct initial assessment and triage of adverse events to determine seriousness and reportability.

• Perform data entry and maintain accurate records in safety databases (e.g., Argus, APEX).

• Conduct duplicate case checks and reconcile information with internal systems and external partners.

• Perform redaction of personally identifiable information (PII) from source documents.

• Translate case reports as needed.

Case Follow-Up:

• Conduct follow-up with reporters (healthcare professionals, patients) to obtain missing information.

• Track and manage case processing timelines and ensure timely completion of all activities.

• Perform quality control checks on processed cases to ensure accuracy and completeness.

Communication & Collaboration:

• Communicate effectively with internal stakeholders (e.g., Medical Information, Regulatory Affairs, Quality Assurance) and external parties as needed.

• Collaborate with the Pharmacovigilance team to ensure efficient case processing and data management.

Country-Specific Requirements:

• Adhere to specific country requirements for case intake and processing, Adhere to specific requirements as outlined in the provided documentation.

• AMERS, EMEA and APAC Countries PII privacy requirements, TGA Health Authority report reception and processing.

• Special handling for fatal cases; SAE reporting requirements for I-SEA countries.

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+ years of experience in pharmacovigilance or a related field (e.g., clinical research, medical information) preferred.

Skills:

• Strong attention to detail and accuracy.

• Excellent organizational and time-management skills.

• Proficiency in data entry and management.

• Strong written and verbal communication skills.

• Ability to work independently and as part of a team.

• Proficiency in English language; fluency in other languages (e.g., Spanish, French, German) is a plus.

• Knowledge of medical terminology and pharmacovigilance regulations is preferred.

• Technical Skills:

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

• Experience with safety databases (e.g., Argus, APEX) is a plus.

#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