Remote Senior Drug Safety Physician

Placements24; Gqeberha; Hybrid; ZAR 2,988,000 - 4,315,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Retirement match

Flexible paid time off

Remote work

Job summary

Placements24 is seeking a Remote Senior Drug Safety Physician to oversee pharmacovigilance for assigned products and ensure patient safety and regulatory compliance globally. The role focuses on medical assessment of adverse events, signal detection, and risk management with remote collaboration across international teams.

The position requires MD or equivalent with 7+ years in drug safety, deep regulatory knowledge, and strong communication.

Qualifications

• Minimum of 7 years of pharmacovigilance or drug safety experience in pharma/biotech.
• Proven ability to assess adverse events, detect signals and manage risk.
• Strong communication skills and experience working with global teams.

Responsibilities

• Oversee medical assessment of adverse event data and causality.
• Lead safety signal detection from multiple data sources.
• Develop and implement risk management plans (RMPs) and REMS.
• Contribute to PSURs, PBRERs, and regulatory safety documents.
• Act as medical lead during clinical trials and safety monitoring.

Skills

Pharmacovigilance expertise

Remote work experience

Medical doctor

Regulatory knowledge

Leadership/mentoring

Education

MD or equivalent

Tools

Safety databases

Office software

Job description

About the Role

Our client is a dynamic and rapidly growing pharmaceutical company seeking a highly experienced Remote Senior Drug Safety Physician . This critical role will oversee the pharmacovigilance activities for assigned products, ensuring patient safety and regulatory compliance on a global scale. You will be responsible for the medical assessment of adverse event data, signal detection, risk management planning, and contributing to regulatory submissions. As a remote-first position, you will leverage advanced communication tools and demonstrate exceptional self-discipline and time management skills to collaborate effectively with international teams. This is an unparalleled opportunity to contribute significantly to patient safety from the comfort of your own home, working with cutting-edge therapies and a highly collaborative global team.

Key Responsibilities

• Provide medical expertise for the assessment of adverse event reports, including case review, causality assessment, and seriousness determination.
• Lead the detection and evaluation of safety signals from various data sources (spontaneous reports, clinical trials, literature, etc.).
• Develop and implement risk management plans (RMPs) and risk evaluation and mitigation strategies (REMS).
• Contribute to the preparation of periodic safety update reports (PSURs/PBRERs) and other regulatory safety documents.
• Act as the medical lead for safety-related issues during clinical trials, including protocol development and safety monitoring.
• Liaise with regulatory authorities on safety matters, responding to inquiries and ensuring compliance.
• Collaborate with cross-functional teams, including regulatory affairs, clinical development, and medical affairs, on safety-related issues.
• Participate in safety review meetings and provide medical input on clinical study designs and data interpretation.
• Mentor and train junior members of the drug safety team.
• Stay current with global pharmacovigilance regulations and guidelines.

Requirements

• Medical Doctor (MD) or equivalent degree (e.g., DO, MBBS) with board certification in a relevant specialty.
• A minimum of 7 years of experience in drug safety/pharmacovigilance within the pharmaceutical or biotechnology industry.
• In-depth knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, CIOMS).
• Proven experience in medical assessment of adverse events, signal detection, and risk management.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong written and verbal communication skills, with the ability to articulate complex medical and safety information clearly.
• Experience working in a remote environment with excellent self-management and communication skills.
• Ability to work independently and collaboratively with global teams.
• Proficiency in using safety databases and standard office software.

Benefits

• Our client offers a highly competitive remote salary, comprehensive health, dental, and vision insurance, a generous retirement savings plan with company match, and flexible paid time off.
• We provide a robust virtual onboarding process and ongoing support for professional development, including access to online training, webinars, and relevant scientific conferences.
• This remote position offers unparalleled flexibility and the opportunity to significantly impact global patient safety without the need for relocation.
• You will be part of an innovative and supportive team that values collaboration and results.