Responsibilities
- Directing the gathering, assessment, and handling of adverse event data to meet regulatory timelines and internal protocols.
- Analyzing safety information thoroughly to detect patterns and potential safety concerns needing follow-up.
- Authoring and filing detailed periodic safety reports and other regulatory submissions in line with international requirements.
- Working closely with clinical and medical staff to evaluate the medical significance of adverse events and support risk mitigation strategies.
- Ensuring pharmacovigilance databases are accurately maintained and adhere to data quality standards.
- Delivering training and guidance to less experienced team members on safety monitoring procedures and regulatory expectations.
- Supporting regulatory audits and inspections by maintaining compliance with pharmacovigilance standards and documentation practices.
- Monitoring updates in global regulations and industry standards to improve organizational safety processes.
Benefits
- Multiple annual leave options available.
- Diverse health insurance plans tailored to individual and family needs.
- Competitive retirement savings programs designed to support long-term financial planning.
- Access to a 24/7 global Employee Assistance Program through TELUS Health, connecting employees and families with over 80,000 specialized professionals.
- Life insurance coverage provided.
- Optional country-specific benefits such as childcare subsidies, bicycle purchase programs, gym discounts, subsidized transit passes, and health screenings.
Work Arrangement
Remote (Worldwide)
Other
- Position based in Brazil with fully remote work arrangement.
- Requires strong English language skills.
