Medical Safety Lead: Pharmacovigilance & Signals

Hungry Lion Fast Foods (Pty) Ltd; Wes-Kaap; Presencial; ZAR 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

IQVIA is seeking an Associate Medical Safety Director for Sponsor Dedicated to join our Lifecycle Safety Medical team. You will provide pharmacovigilance expertise across safety activities, including signal detection, risk management, and regulatory reporting for allocated product portfolios.

The role requires a medical degree and about three years of clinical practice with pharma industry exposure, plus strong ability to synthesize data and communicate complex issues to cross-functional teams,

Formación

• Medical degree from an accredited and internationally recognized medical school.
• Approximately three years of clinical practice with two years in the pharmaceutical or related industry.

Responsabilidades

• Providing aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile
• Leads signal detection and analysis, including, signal detection strategy, frequency, and timing, reviews the Signal Detection Reports and other sources of data as applicable, raises potential signals for team discussion, contributes to safety analysis reports presentations of signal evaluation data as appropriate
• Providing medical review and contribution to IND Annual Reports, EU Periodic Benefit Risk Evaluation Reports, EU Periodic Safety Update Reports, EU Development Safety Update Reports, US Periodic Reports
• Providing medical review and contribution to Development Risk Management Plans, EU Risk Management Plans or US Risk Evaluation and Mitigation Strategies
• Review and contribute to benefit-risk evaluation of drugs in clinical trial and post marketing set up
• Providing safety oversight and contribution for label development, review, and updates
• Provide medical safety contributions to the Integrated Safety Summary or Common Technical Document
• Performing medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs) including narrative content, queries, coding, expectedness, seriousness, causality, and company summary and serve as an internal consultant to pharmacovigilance case processing teams
• Representing safety and clinical data review findings during internal and external stakeholder meetings
• Providing medical safety support, contribution, and attendance at Safety Governance and other Meetings as needed

Conocimientos

Signal detection

Aggregate reports

Risk management

Data synthesis

Communication

Educación

Medical degree from accredited medical school

Descripción del empleo

IQVIA is seeking an Associate Medical Safety Director for Sponsor Dedicated to join our Lifecycle Safety Medical team. You will provide pharmacovigilance expertise across safety activities, including signal detection, risk management, and regulatory reporting for allocated product portfolios.

The role requires a medical degree and about three years of clinical practice with pharma industry exposure, plus strong ability to synthesize data and communicate complex issues to cross-functional teams,