Senior Medical Writer

Parexel; Bloemfontein; Hybrid; ZAR 500,000 - 700,000; Full time

Job summary

Parexel, a global leader in biopharmaceutical services, is seeking a Senior Medical Writer in Bloemfontein. This role involves critical signal management, collaboration with safety teams, and mentoring junior staff. Candidates should possess extensive experience in pharmacovigilance, strong analytical abilities, and a relevant Life Sciences degree.

Qualifications

• Relevant experience in Regulatory / Pharmacovigilance or related fields desirable.
• Good knowledge of medical terminologies required.

Responsibilities

• Responsible for comprehensive signal management, including detection, analysis, and evaluation.
• Oversee end-to-end signal management and train junior staff.

Skills

Pharmacovigilance

Analytical Skills

Communication

Problem Solving

Education

University degree in Life Sciences, Health, or Biomedical Sciences

Degrees in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing

Job description

When our values align, there's no limit to what we can achieve.

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values: Patients First, Quality, Respect, Empowerment & Accountability.

We are currently recruiting a Senior Medical Writer based in South Africa, who will work as part of the Drug Safety writing team.

The Senior Medical Writer is responsible for comprehensive signal management, including detection, analysis, and evaluation from various sources. They oversee the end-to-end signal management process, collaborate with client safety science teams, and adhere to client-defined plans and SOPs. The PMW also contributes to preparing, updating, and managing safety documents such as Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other aggregate reports. This role requires expertise in pharmacovigilance processes and the ability to manage complex safety data.

This position also involves training junior staff, requiring strong communication and problem-solving skills, balancing mentoring with client relations. Expertise in pharmacovigilance, strong analytical skills, and the ability to collaborate across functions are essential to ensure comprehensive product safety management across multiple therapeutic areas.

Knowledge and Experience :

• Relevant experience in Regulatory / Pharmacovigilance or related fields is desirable.
• Good knowledge of medical terminologies.

Education :

• Minimum of a university degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics).
• Degrees in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing, which involve patient exposure in hospital-based environments, would be an advantage.

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Medical Writer • Remote, Bloemfontein, South Africa