Clinical Pharmacovigilance/Drug Safety
Job Summary
Responsible for providing medical and clinical insight and guidance through clinical trials for pharmaceuticals.
Primary Responsibilities
- Provide medical and clinical guidance to managers before, throughout, and following clinical trials.
- Maintain consistency of safety assessments.
- Perform a variety of safety assessments.
- Serve in cross-functional teams as a medical and scientific representative.
- Ensure regulatory compliance and safety throughout trial.
- Submit periodic reports to the Food and Drug Administration.
- Ensure that medical and causality assessments of all clinical and post-marketing adverse event fillings to foreign regulatory authorities are consistent with company policies, as well as the respective foreign regulatory requirements.
- Address labeling concerns and updates.
- Interpret regulatory mandates.
- Assist with internal and external drug safety audits
- Create company data sheets.
- Remediate any pharmacovigilance deficiencies found during regulatory or internal audits.
- Act as medical expert during product development.
- Ensure subject safety during clinical studies.
- Establish and maintain consistency of safety assessments within the US and outside the US.
- Identify the correct actions and facilitate, support and implement them as appropriate.
- Review performance metric data and clarify inconsistencies and trends.
