Pharmacovigilance Regulatory Reporting Specialist

As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities.

Review, assess, and process safety data and information received from various sources. Distribute reports/data to internal and external third parties following applicable regulations, Standard Operating Procedures (SOPs), and internal guidelines under the guidance and support of senior operation team members.

Essential Functions

• Process safety data according to applicable regulations, guidelines, SOPs, and project requirements.
• Ensure compliance with quality, productivity, and delivery standards per project requirements.
• Track cases as applicable to the project plan.
• Identify and report quality problems to senior team members.
• Liaise with different functional team members and health care professionals to address project-related issues.
• Attend project team meetings and provide feedback to the operations manager on challenges, issues, or successes.

Qualifications

• Bachelor's degree in life sciences

• Languages: Advanced level of English

• 2-3 years of experience in pharmacovigilance activities (mandatory) Specifically in regulatory reporting, will be highly valued.

• Previous experience working with Argus is required

• Good knowledge of medical terminology and applicable safety databases.

• Strong organizational skills, attention to detail, and ability to work independently and as part of a team.

Work modality:

100% home-based