Leading Pharmaceutical Company Seeks Pharmacovigilance Talent to join there dynamic team
Clinical Pharmacovigilance /Drug Safety
Responsible for providing medical and clinical insight and guidance through clinical trials for pharmaceuticals.
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.
Degree in Pharmacology /Pharmacist or similar
Must come from Pharmaceutical environment
Good command of the English Language and French
Medical Aid and Pension and Provident Fund
Please click here to apply.