Associate Medical Safety Director

8+ years

Not Disclosed

Remote, USA

10 Aug. 22, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Medical Safety Director - South Africa (Office-Based/Hybrid/Home-Based)

About Us:

IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services for the life sciences industry. We push the boundaries of human and data science to drive impactful solutions and help create a healthier world.

Role Overview:

We are seeking an Associate Medical Safety Director to provide expert medical, scientific, and therapeutic oversight within our pharmacovigilance services. This role involves contributing to all aspects of medical safety, including risk management, signal detection, and regulatory reporting. The position offers flexibility to be based in the office, hybrid, or home-based in South Africa.

Key Responsibilities:

Aggregate Safety Reviews: Conduct comprehensive reviews of safety data, including clinical information, to maintain a thorough understanding of product safety profiles.
Signal Detection and Analysis: Lead signal detection activities, develop signal detection strategies, and review Signal Detection Reports. Identify and discuss potential safety signals and contribute to safety analysis reports and presentations.
Regulatory Reporting: Provide medical reviews and contributions to various reports including IND Annual Reports, EU Periodic Benefit-Risk Evaluation Reports, US Periodic Reports, and Risk Management Plans.
Benefit-Risk Evaluation: Review and contribute to benefit-risk assessments of drugs in both clinical trials and post-marketing settings.
Labeling and Safety Documentation: Oversee the development, review, and update of product labels and provide medical safety contributions to Integrated Safety Summaries and Common Technical Documents.
Case Review and Consultation: Perform medical evaluations of trial-related Adverse Events (AEs) and post-marketing Adverse Drug Reactions (ADRs). Review narrative content, queries, coding, and causality, and serve as a consultant to pharmacovigilance teams.
Stakeholder Engagement: Represent safety and clinical data findings in internal and external meetings. Provide support and contributions during Safety Governance and other relevant meetings.

Qualifications and Skills:

Medical Degree: Accredited and internationally recognized medical degree.
Experience: Approximately three years of clinical practice experience plus two additional years in the pharmaceutical industry, or a comparable combination of education and experience.
Regulatory Knowledge: Understanding of federal and local regulations related to clinical research, safety, and good clinical practice.
Product Knowledge: Maintain up-to-date knowledge of assigned product portfolios, therapeutic areas, and relevant literature.
Technical Skills: Experience in signal detection, aggregate report preparation, and risk management. Ability to synthesize and analyze data from various sources and communicate complex issues clearly.
Project Management: Strong skills in prioritizing, meeting deadlines, and managing objectives under pressure. Demonstrated flexibility and initiative in adapting to changing business needs.
Interpersonal Skills: Ability to establish and maintain effective working relationships with colleagues, managers, and clients, including providing mentorship as needed.

Why Join Us?

At IQVIA, we are committed to driving innovation and excellence in everything we do. In addition to a competitive salary, we offer a range of benefits tailored to support your well-being and work-life balance. To learn more about our benefits and apply for this role, please visit our careers page.

Equal Opportunity Employer:

IQVIA is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you need accommodations due to a medical condition or disability, please let us know or submit a request here.

Apply Today:

If you’re ready to make a difference and meet the qualifications for this role, we encourage you to apply. Whether this role is a perfect fit or if another opportunity at IQVIA aligns with your skills, we look forward to hearing from you.