Job: Intern: Library X20

Company : Council For Geoscience; South Africa; On-site; ZAR 1,200,000 - 1,800,000; Full time

Job summary

IQVIA in South Africa seeks an Associate Medical Safety Director to lead pharmacovigilance activities across sponsor-dedicated programs. You will provide medical safety oversight, evaluate risks, and contribute to regulatory reporting and signal management.

Applicants should have a medical degree and several years of clinical and industry experience, with strong capability to synthesize data, communicate complex issues, and mentor junior staff.

Qualifications

• Medical degree from an accredited and internationally recognized medical school
• Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice and clinical trials and pharmaceutical research process
• Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature
• Experience in Signal detection, Aggregate reports and Risk management
• Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing
• Ability to establish and meet priorities, deadlines, and objectives
• Demonstrated skills in contributing to multiple assignments required, capacity to work under pressure as well as initiative and flexibility and ability to adapt to changing business needs
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed

Responsibilities

• 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

Skills

Medical degree

Clinical practice

Regulatory knowledge

Data synthesis

Time management

Mentorship

Education

Medical degree

Job description

Associate Medical Safety Director- Sponsor Dedicated

Belgrade, Serbia
Lisbon, Portugal
Budapest, Hungary
Bloemfontein, South Africa
Zagreb, Croatia
Centurion, South Africa
Prague, Czech Republic
Sofia, Bulgaria
New Cairo, Egypt
Bellville, South Africa
Istanbul, Turkey
Full time
R

Our ever-growing Lifecycle Safety Medical team is expanding. The role participates in all aspects of the Medical Safety activities as per scope of work. This includes, but is not limited to providing and maintaining of PV and risk management expertise to internal and external stakeholders, maintaining knowledge relevant to allocated product portfolios, conducting medical evaluation of post-marketing adverse drug reactions, review and contribution to signal management and benefit-risk evaluation of drugs in clinical trial and post marketing set up, preparation, and/or contribution to responses to questions from health authorities, reviewing and contributing to periodic aggregate reports, contributing to safety review of study protocols, investigators brochure and other reference safety information, and serving as an internal consultant for any medical support for pharmacovigilance operations.

Role responsibilities

• 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

Skills, experience and qualifications required for the role

• A medical degree from an accredited and internationally recognized medical school
• Around three years of clinical practice experience with two additional years in the pharmaceutical or associated industry, or equivalent combination of education, training and required experience
• Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research including knowledge of regulations and guidelines pertaining to safety and good clinical practice and clinical trials and pharmaceutical research process
• Maintain knowledge of assigned product portfolio, therapeutic area, and recent literature
• Experience in Signal detection, Aggregate reports and Risk management.
• Capability to synthesize and critically analyze data from multiple sources and communicate complex clinical issues and analyses orally and in writing
• Ability to establish and meet priorities, deadlines, and objectives
• Demonstrated skills in contributing to multiple assignments required, capacity to work under pressure as well as initiative and flexibility and ability to adapt to changing business needs
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients, including mentorship if needed

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later,