Safety Associate

Safety Associate

The Safety Associate 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 role helps ensure incoming safety information is appropriately monitored, tracked, reconciled and routed in accordance with applicable procedures, while providing trained backup coverage for designated AEI processes.

The ideal candidate is highly organized, detail-oriented, and possesses strong communication and problem-solving skills.

Key Responsibilities:

• Monitor assigned AEI/safety mailboxes according to established procedures and coverage schedules.
• Review incoming communications and identify items requiring AEI attention.
• Support appropriate routing/escalation of safety-related communications to the team responsible.
• Support acknowledgement and mailbox tracking activities.
• Maintain mailbox organization and appropriate operational records.
• Escalate unclear, urgent or potentially non-compliant items to the appropriate AEI specialist/lead.
• Perform scheduled reconciliation of designated AEI mailboxes against applicable trackers or source records.
• Support identification of missing, duplicate or potentially unprocessed communications.
• Document reconciliation results according to the applicable process.
• Escalate discrepancies for review and resolution.
• Support follow-up and closure of reconciliation findings.
• 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.
• 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.
• Execute assigned activities in accordance with applicable SOPs, work instructions and project requirements.
• Complete required training before independently performing assigned activities.
• Maintain accurate and complete operational documentation.
• Promptly escalate errors, discrepancies, potential compliance issues or activities outside the authorized role's scope.
• Participate in corrective/preventive or quality-improvement activities when applicable.
• 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.
• 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.
• 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 life science field (e.g., biology, pharmacy, nursing, health sciences, chemistry) 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. Interest or initial experience in pharmacovigilance, drug safety, clinical research or healthcare operations.

Skills:

• Strong attention to detail and accuracy
• Ability to work with controlled procedures
• Excellent organizational, time-management skills and prioritization 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
• Ability to identify discrepancies and escalate appropriately

Preferred Qualifications:

• Experience with electronic data capture (EDC) systems
• Knowledge of medical terminology and coding systems (e.g., MedDRA)
• Experience with regulatory submissions

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.

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.