Senior Drug Safety Physician

Soterius, Inc.; Oregon; Hybrid; USD 150,000 - 210,000; Full time

Job summary

Soterius, Inc. is seeking a Senior Drug Safety Physician with strong medical assessment and pharmacovigilance expertise to support aggregate reporting, signal management, risk management, and regulatory safety activities in compliance with applicable regulations and SOPs.

You will perform medical reviews of aggregate reports, contribute to medical assessments and responses to Health Authorities, and own RMP authoring and risk minimization efforts.

Qualifications

• MBBS/MD in an appropriate medical specialty.
• 3–5 years of relevant experience in pharmacovigilance or drug safety.
• Experience in aggregate reports, signal management, RMPs, and regulatory safety documentation.
• Strong clinical judgement, analytical skills, and scientific writing abilities.
• Good communication, collaboration, and stakeholder management skills.

Responsibilities

• Perform medical review of aggregate reports (PBRER, DSUR, PADER) and literature screening.
• Contribute to medical assessments, Health Authority responses, and signal management.
• Review product safety data and communicate findings through safety governance forums.
• Own and manage Risk Management Plan (RMP) authoring and risk minimization activities.
• Provide medical and pharmacovigilance input to protocols, IBs, CSRs, and regulatory safety documents.
• Participate in safety governance meetings, DMCs, and Adjudication Committees, as applicable.
• Collaborate with Safety Scientists, Medical Affairs, and Regulatory Affairs teams.
• Develop and review SOPs, Work Instructions, and safety-related processes.
• Ensure compliance with pharmacovigilance regulations, project guidelines, and company SOPs.
• Support training and mentoring of team members and maintain awareness of evolving regulatory requirements.

Skills

Pharmacovigilance

Drug safety

Clinical judgment

Analytical skills

Scientific writing

Stakeholder management

Education

MBBS/MD

Job description

We are looking for a Senior Drug Safety Physician with strong medical assessment and pharmacovigilance expertise to support aggregate reporting, signal management, risk management, and regulatory safety activities in compliance with applicable regulations and SOPs.

Key Responsibilities

• Perform medical review of aggregate reports, including PBRER, DSUR, and PADER, and conduct scientific literature screening.
• Contribute to medical assessments, Health Authority responses, and signal detection, evaluation, and management.
• Review product safety data and communicate findings through safety governance forums.
• Own and manage Risk Management Plan (RMP) authoring and risk minimization activities.
• Provide medical and pharmacovigilance input to protocols, Investigator’s Brochures, Clinical Study Reports, and regulatory safety documents.
• Participate in safety governance meetings, DMCs, and Adjudication Committees, as applicable.
• Collaborate with Safety Scientists, Medical Affairs, and Regulatory Affairs teams.
• Develop and review SOPs, Work Instructions, and safety-related processes.
• Ensure compliance with pharmacovigilance regulations, project guidelines, and company SOPs.
• Support training and mentoring of team members and maintain awareness of evolving regulatory requirements.

Required Qualifications and Skills

• MBBS/MD in an appropriate medical specialty.
• 3–5 years of relevant experience in pharmacovigilance or drug safety.
• Experience in aggregate reports, signal management, RMPs, and regulatory safety documentation.
• Strong clinical judgment, analytical skills, and scientific writing abilities.
• Good communication, collaboration, and stakeholder management skills.