Safety Process Specialist with Pharmacovigilance Expertise
6 days ago
We are seeking a highly skilled Safety Process Specialist to join our team at Organon, a global healthcare company dedicated to delivering ingenious health solutions. The ideal candidate will have extensive experience in pharmacovigilance and safety processes.
The primary responsibility of this role is to maintain and perform the necessary processes to ensure high-quality and compliant reporting of aggregate safety reports in accordance with PV regulations.
The successful candidate will be responsible for:
- Performing quality review and compliance monitoring of aggregate safety reports to Health Authorities and Business Partners adhering to regulatory requirements
- Measuring quality effectiveness by tracking appropriate metrics and evaluating key performance indicators
- Extracting, calculating, and overall QC of patient exposure for aggregate reports
- Monitoring the quality of aggregate safety reports and ensuring internal and regulatory compliance
- Partnering with internal and external stakeholders to identify, prioritize, and monitor quality and compliance issues and developing solutions to minimize risk and ensure the overall quality of aggregate safety reports
To be successful in this role, you will need to possess:
- A bachelor's degree or master's degree in a life science/healthcare/pharmaceutical-related field
- Knowledge of PV principles, systems, and requirements, as well as PV regulations
- Strong analytical skills and quality focus
- Problem-solving, conflict resolution, and critical thinking skills
- Ability to function with a high degree of autonomy, quickly adapt to changes in business priorities, and effectively manage competing priorities
This is an exciting opportunity to work with a talented team of professionals who share your passion for delivering high-quality health solutions. As a Safety Process Specialist at Organon, you will have the chance to contribute to the development of innovative products that make a meaningful difference in people's lives.
Salary Range: $80,000 - $120,000 per annum (depending on location)
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