What are the responsibilities and job description for the Pharmacovigilance Compliance Specialist position at Integrated Resources, Inc ( IRI )?
Summary :
The Pharmacovigilance (PV) Compliance Specialist is responsible for ensuring that the company’s pharmacovigilance activities are in full compliance with global regulations, guidelines, and internal procedures. This includes monitoring and overseeing the adherence to safety reporting standards, conducting audits and inspections, preparing regulatory submissions, and supporting the overall PV quality assurance efforts. The role also involves staying updated on changes in legislation and regulatory requirements.
Responsibilities :
- Will be responsible to submit service tickets for vendor employees in appropriate ticketing system(s)
- Review contracts to verify use of correct exhibit language; issue email notifications for time sensitive activities such as overdue training
- Assist in the preparation and coordination of internal and external audits of pharmacovigilance activities to ensure adherence to regulatory and internal standards.
- Support the safety data management process, ensuring the accurate and timely submission of adverse event reports in compliance with regulatory timelines.
- Provide support for vendors / suppliers
- Maintain accurate records and documentation related to pharmacovigilance activities to ensure compliance with regulatory agencies and internal quality systems.
- Ensure that safety reports and other pharmacovigilance documents are consistently accurate, complete, and submitted within required timelines.
- Other responsibilities as deemed appropriate for coordinator role to support compliance to pharmacovigilance requirements.
Qualifications :
