Safety Aggregate Report & Analytics Specialist 2

This is a fully remote position, open to applicants in Argentina.

📋 Description

• Lead the creation and presentation of essential aggregate safety reports, such as PBRERs/PSURs, DSURs, PADERs, RMPs, ACOs, and line listings.

• Act as the main owner of designated safety deliverables, ensuring they meet quality standards, compliance, and are completed on schedule.

• Oversee signal management activities, which encompass signal detection, validation, and assessment.

• Conduct risk assessment and characterization.

• Document and monitor safety signals.

• Develop and implement signaling strategies.

• Manage literature surveillance for both commercialized and investigational products.

• Write responses to inquiries from regulatory authorities and assist with safety labeling and benefit-risk documentation.

• Work collaboratively with global stakeholders across Pharmacovigilance, Regulatory Affairs, Medical Writing, Clinical Research, Quality, and Safety Operations.

• Provide mentorship and support to junior team members.

• Assist with audits, inspections, process enhancements, and innovation initiatives.

• Propel project success through effective stakeholder management, communication, and leadership.

⛳️ Requirements

• Bachelor's degree in a Life Sciences discipline.

• 2-4 years of experience in post-marketing pharmacovigilance, focusing on aggregate reporting, signal management, and benefit-risk assessment.

• Proficient level of English.

• Comprehensive understanding of global pharmacovigilance regulations and guidelines, including GVP, GCP, and ICH.

• Experience in authoring or leading aggregate safety reports and regulatory submissions.

• Strong skills in project management and stakeholder engagement.

• Exceptional analytical capabilities, attention to detail, and proficiency in written communication.

• Capacity to work independently while juggling multiple priorities in a dynamic global setting.

🏝️ Benefits

• Engage in significant global safety programs that directly enhance patient safety.

• Collaborate with international teams and top pharmaceutical and biotech clients.

• Broaden your expertise in aggregate reporting, signal management, risk management, and regulatory strategy.

• Develop your leadership abilities through mentorship, client engagement, and project responsibility.

• Join a team that prioritizes innovation, ongoing learning, and professional growth.