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Cape Town

Hybrid

ZAR 1,200,000 - 1,800,000

Full time

44 hours ago
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Job summary

IQVIA seeks a dedicated Associate Medical Safety Director to support pharmacovigilance with medical safety expertise across post-marketing and development programs. The role covers safety signal detection, review of safety data, and regulatory reporting, contributing to risk management and benefit-risk assessments.

Candidates should hold a medical degree and have 3+ years of clinical practice with pharma exposure, plus knowledge of safety regulations and real-world pharmacovigilance practices.

Qualifications

  • Medical degree and clinical practice knowledge.
  • Experience in signal detection, aggregate reports and risk management.
  • Strong ability to synthesize data from multiple sources and communicate complex issues.

Responsibilities

  • Provide aggregate safety reviews and oversee product safety profiles.
  • Lead signal detection and analysis, and contribute to safety reports.
  • Provide medical review for regulatory documents and safety reports.
  • Mentor and collaborate with team members and stakeholders.
  • Represent safety findings in internal and external meetings.

Skills

Signal detection
Aggregate reports
Risk management
Data synthesis
Communication
Project coordination

Education

Medical degree

Job description

**Company Description**
**AECOM** is seeking a Principal Engineer - General Civilsto be based in South Africa's Enterprise Capabilities office in **Bellville, Cape Town** . This position will support a team locally based in South Africa and Global Teams. As a part of AECOM's culture, it offers a flexible hybrid work arrangement which accommodates both office and out-of-office work schedules.
**About Enterprise Capabilities**
Fundamental to our _Think and Act Globally_ strategy and digital adoption, Enterprise Capabilities (EC) is AECOM's primary vehicle for workshare. Operating across geographic boundaries and time-zones, EC partners with regional and Global Business Line project teams to provide technical expertise, accelerate delivery and keep AECOM competitive in the industry.
With a team of over 3000 technical professionals located across nine countries and remote technical anchors, EC teams are trusted to deliver high-quality, specialist services that help to fill capability gaps, resourcing needs and technical constraints on projects of all scopes and sizes.
**Start here. Grow here.**

**Job Description**
**Role Description**

  • Lead the design and planning of civil engineering infrastructure such as earthworks/grading, roads, stormwater, sewer and water for projects across various market sectors.
  • The role will also entail Client liaison, reporting, design review, coordination, management of resources, overall oversight in terms of typical deliverables e.g. design calculations, reports, drawings, bill of quantities, technical specifications and project documentation.
  • Mentors subordinate staff.
  • Coordinate/manage/lead small to mid-sized teams on a project by project basis.
  • Ensures the execution of projects in accordance with AECOM Quality Management System requirements.
  • Performs specific and moderate/complex portions of a broader assignment as an experienced professional engineer. Provides specialised technical input into studies and design work for the infrastructure design discipline and identifies discrepancies in results.
  • Follows existing or develops design procedures to facilitate high-quality, cost-effective work by self and others.
  • Gathers and correlates engineering data using established and well-defined procedures.
  • Prepares technical specifications.
  • Monitors performance in terms of budget, quality and schedule.
  • Solves problems encountered using knowledge, innovation and modifications of standard procedures or methods developed in previous works.
  • Contributes to the area of expertise, providing proposed improvements to existing processes and delivers solutions where precedent may not exist.
  • Performs technical quality reviews of design calculations, BIM models and drawings, including documentation in project record by adhering to occupational health and safety and corporate standards.
  • Develops construction cost estimates and estimates of technical effort/man-hours for projects. Maintains and develops the highest level of technical skills and abilities.
  • Support in building and maintaining Client(internal and external) relationships. Attends client meetings as a technical lead to gather information and discuss project requirements, explain/ defend work, etc. Participates in the development and preparation of bids and proposals (as required)-the ability to present solutions to clients in a professional and technically competent manner.

**Skills**

  • Solid experience in the design of civil infrastructural elements (earthworks/grading, roads, stormwater, sewer and water - utilities), particularly in a multi-disciplinary project delivery environment, across all project stages, across varying market sectors
  • Strong proficiency in AutoCAD Civil 3D
  • Good working knowledge of ProjectWise and BIM360 / ACS. Experience in the execution of multi-disciplinary projects through BIM
  • Experience in 12D Model is advantageous
  • Experience working in other (international) standard specifications and/or design guidelines will be advantageous. Australia and New Zealand in particular.
  • Good communication skills (written and verbal)
  • Demonstrate experience in leading/managing infrastructure projects

**Qualifications**

  • Bachelor of Science or Engineering
  • 12+ relevant experience post qualification
  • Professionally registered with ECSA and/or CPEng/CMEngNZ
  • Own reliable transport

**Additional Information**
_At AECOM, our Freedom to Grow philosophy supports flexibility and balance to help our people thrive. As part of this approach, we ask all hybrid employees to work from an AECOM office at least three days per week._
_At AECOM, we are committed to maintaining a secure and trustworthy recruitment process and take any fraudulent hiring activity seriously._ **_To support this commitment, all newly hired employees are required to attend an in-person Day 1 onboarding at an AECOM office location as a condition of employment._**

**About AECOM**
AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options, well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, employee stock purchase plan.
AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients' complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle - from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of $16.1 billion in fiscal year 2025. Learn more at aecom.com.

**What makes AECOM a great place to work**
You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you'll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you've always envisioned. Here, you'll find a welcoming workplace built on respect, collaboration and community - where you have the freedom to grow in a world of opportunity.
As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines.

**ReqID:** J
**Business Line:** Transportation
**Business Group:** DCS
**Strategic Business Unit:** Enterprise Capabilities
**Career Area:** Engineering
**Work Location Model:** Hybrid

Associate Medical Safety Director- Sponsor Dedicated

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 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.
Associate Medical Safety Director
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

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.
EEO Minorities/Females/Protected Veterans/Disabled

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