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Primary Responsibilities:
- Author aggregate safety reports (PBRER, PSUR, DSUR, etc.) for submissions to health authorities.
- Plan report timelines, coordinate with stakeholders, and review safety data.
- Mentor team members, conduct training, and ensure compliance with regulatory guidelines.
Secondary Responsibilities:
- Organize work, manage multiple deliverables, and meet timelines.
- Provide functional guidance and technical support to junior team members.
- Ensure accuracy, completeness, and compliance with quality standards.
Candidate Profile:
- Bachelor's or Master's degree in life sciences or healthcare.
- 5-8 years of experience in pharmacovigilance or aggregate reporting.
- Advanced knowledge of global regulatory requirements and drug safety.
ClinChoice
ClinChoice partners with pharmaceutical, medical device, and consumer care companies to accelerate clinical trials and ensure product safety. With a global delivery network spanning multiple countries, they provide expertise in clinical operations, biometrics, pharmacovigilance, and more.