Pharmacovigilance Specialist Argus
hace 11 horas
We are seeking a highly skilled Pharmacovigilance Specialist to join our team at Iqvia. As a key member of our Safety team, you will be responsible for ensuring the quality and integrity of safety data, while providing exceptional support to our clients.
Key Responsibilities- Process safety data in accordance with applicable regulations, guidelines, and project requirements.
- Enter data into databases and determine the initial or updated status of incoming events.
- Coding adverse events and products, writing narratives, and conducting literature-related activities, as well as quality review and reconciliation.
- Assess safety data for reportability to relevant authorities and track reportable cases.
- Report to regulatory authorities, ethics committees, institutional review boards, investigators, and oversight groups within timelines and in a format compatible with project requirements.
- Liaise with stakeholders to facilitate expedited reporting.
- Contribute knowledge and expertise to assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance, and Medical Information.
- Ensure quality, productivity, and delivery standards per project requirements.
- Ensure compliance with all project-related processes and activities.
- Build a positive, collaborative team environment and provide training and mentoring to less experienced team members.
- Thorough understanding of project protocol, therapeutic indication, budget, and scope of work.
- Establish and maintain effective team and project service operations communications.
- Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs.
- Ensure all required training is executed in a timely fashion and documented.
We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.
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