Pharma Materials Handler | Sap & Gmp Operations

Biovac; Cape Town; On-site; ZAR 900,000 - 1,300,000; Full time

Job summary

IQVIA is seeking an Associate Medical Safety Director to join the Sponsor Dedicated Lifecycle Safety Medical team in a global role. You will provide and maintain PV expertise, review safety data, contribute to signal management, and support regulatory safety activities across products and studies.

The role requires a medical degree, about three years of clinical practice plus pharmaceutical industry experience, and strong writing and communication skills to interact with health authorities and

Qualifications

• Medical degree from an accredited and internationally recognized medical school.
• Around three years of clinical practice 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.

Responsibilities

• Providing aggregate reviews of safety information to maintain oversight of a product's safety profile.
• Leads signal detection and analysis, including signal detection strategy, frequency, and timing.
• Provides medical review and contribution to regulatory safety reports (IND Annual Reports, EU PRRs, US Periodic Reports).
• Contributes to Development Risk Management Plans and EU/US Risk Management Plans.
• Reviews and contributes to benefit-risk evaluation of drugs in trials and post-marketing setups.
• Provides safety oversight for label development and updates.
• Contributes to Integrated Safety Summary/CTD.
• Reviews AEs and ADRs with narrative content, coding, seriousness, causality, and company summaries.
• Representing safety findings at internal/external meetings.
• Providing medical safety support and attendance at Safety Governance meetings.

Skills

Medical safety expertise

Signal detection

Aggregate reports

Pharmacovigilance

Medical writing

Communication skills

Education

Medical degree from an accredited medical school

Three years clinical practice with two years pharma/industry

Job description

• Belgrade, Serbia
• Budapest, Hungary
• Sofia, Bulgaria
• Bellville, South Africa
• Istanbul, Turkey
• Lisbon, Portugal
• Bloemfontein, South Africa
• Zagreb, Croatia
• Athens, Greece
• Centurion, South Africa
• Prague, Czech Republic
• Evosmos, Greece
• New Cairo, Egypt

Full time

R

Associate Medical Safety Director- Sponsor Dedicated

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-marking 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

Do you have the skills, experience and qualification 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. Learn more at is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. 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, in accordance with applicable law. We appreciate your honesty and professionalism.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.

To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.

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