Drug Safety Physician

Placements24; Cape Town; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Performance bonuses

Medical insurance

Remote work flexibility

Generous leave

Job summary

Placements24 is seeking a Drug Safety Physician to join a global pharmacovigilance team in a fully remote capacity. The role emphasizes medical assessment of adverse event reports, signal detection, and risk management across products throughout their lifecycle.

You will contribute to regulatory safety submissions, support trials, and act as a medical point of contact for regulators and internal stakeholders.

Qualifications

• MD or equivalent required.
• 5+ years in drug safety/pharmacovigilance in the pharma industry.
• Strong knowledge of global pharmacovigilance regulations (ICH, GVP).
• Excellent analytical, problem-solving, and independent work skills.

Responsibilities

• Assess adverse event reports including causality and seriousness.
• Lead signal detection activities and review aggregate safety data.
• Develop medical risk management plans and implement safety strategies.
• Contribute to regulatory safety documents (PSURs, DSURs, RMPs).
• Serve as medical lead for internal teams and regulators.

Skills

Pharmacovigilance

Clinical judgment

Regulatory knowledge

Signal detection

Medical expertise

Education

MD or equivalent

Job description

About the Role

Our client is seeking a highly qualified and experienced Drug Safety Physician to join their global pharmacovigilance team, offering a remote working arrangement. This critical role involves providing medical expertise to ensure the safety of our client's pharmaceutical products throughout their lifecycle. You will be responsible for the medical assessment of adverse event reports, signal detection, risk management strategies, and contributing to regulatory safety submissions. The ideal candidate will possess strong clinical judgment, a deep understanding of drug safety principles and regulations, and excellent communication skills, ensuring the robust safety profile of our pharmaceutical innovations and protecting public health worldwide.

Key Responsibilities

• Provide medical expertise for the assessment of adverse event reports, including case causality and seriousness evaluations.
• Lead and contribute to signal detection activities, performing medical reviews of aggregate safety data.
• Develop and implement medical risk management plans and strategies for assigned products.
• Contribute to the medical review of regulatory safety documents, such as PSURs, DSURs, and RMPs.
• Serve as a medical point of contact for internal teams, regulatory authorities, and external experts on drug safety matters.
• Provide medical input into the design of clinical trials and post-marketing studies.

Requirements

• Medical Doctor (M.D. or equivalent) degree required.
• Board certification or eligibility in a relevant clinical specialty is highly desirable.
• Minimum of 5 years of experience in drug safety/pharmacovigilance within the pharmaceutical industry.
• In-depth knowledge of global pharmacovigilance regulations and guidelines (e.g., ICH, GVP).
• Strong clinical acumen and experience in evaluating drug-related adverse events.
• Excellent analytical, problem-solving, and decision-making skills, with the ability to work independently in a remote setting.

Benefits

• Highly competitive annual salary and potential for significant performance bonuses.
• Comprehensive medical, dental, vision, and life insurance coverage.
• Flexible remote work arrangement offering excellent work-life balance.
• Generous paid time off, including vacation, sick leave, and holidays.
• Opportunities for continued medical education and professional development.
• A pivotal role in ensuring global patient safety for innovative medicines.