Drug Safety Physician

Soterius, Inc.; Mumbai; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Soterius, Inc. seeks a Medical Review professional with 1–2 years in pharmacovigilance to assess adverse event cases and provide clinical judgment across case processing and aggregate reports.

The role emphasizes causality, seriousness, and expectedness assessments, with strong attention to detail and regulatory liaison skills. Candidate should have MBBS or MD in Pharmacology, experience in line listing, and the ability to deliver high-quality safety evaluations within a large-volume

Qualifications

• 1–2 years of pharmacovigilance or drug safety experience.
• MBBS or MD in Pharmacology required.
• Clinical judgment and strong communication skills essential.

Responsibilities

• Perform medical review of ICSD R including causality, seriousness, and expectedness.
• Conduct line listing reviews for non-serious cases per SOPs.
• Provide benefit-risk assessments and medical input.
• Contribute medical input to aggregate reports.
• Support responses to regulatory queries.
• Support product safety and consumer health safety assessments.
• Ensure medical review activities meet quality and compliance standards.
• Escalate safety concerns and complex cases appropriately.

Skills

Medical review

ICSR causality

ICSR seriousness

ICSR expectedness

Line listing

Benefit-risk assessment

Aggregate report input

Regulatory queries

Argus

LSMV

Education

MBBS

MD in Pharmacology

Job description

Responsible for the medical review of adverse event cases within a large-volume OTC/consumer healthcare pharmacovigilance program. Provides clinical judgment across case processing and aggregate report activities.

Qualifications and Experience

• 1 to 2 years of experience in pharmacovigilance, drug safety, or clinical safety.
• MBBS, MD in Pharmacology.

Key Responsibilities

• Perform medical review of ICSD R, including causality, seriousness, and expectedness assessment.
• Conduct line listing review for non-serious cases in line with program SOPs.
• Provide benefit-risk evaluation and medical input.
• Provide medical input to aggregate reports.
• Support responses to medical aspects of regulatory queries.
• Support product safety and consumer health safety assessments.
• Ensure medical review activities meet quality and compliance standards.
• Escalate safety concerns and complex cases appropriately.

Key Skills

• Medical review and clinical assessment of ICSD R.
• ICSR causality, seriousness, and expectedness assessment.
• Line listing and product safety review.
• Benefit-risk assessment and aggregate report medical input.
• Regulatory query and safety assessment experience.
• Strong clinical judgment, analytical skills, attention to detail, and communication skills.
• System and Domain Exposure
• Pharmacovigilance safety databases such as Argus, LSMV, or equivalent.
• ICSR processing and medical review workflows.

Required Skills

MBBS MD benefit-risk line listing review seriousness expectedness medical review Physician consumer health aggregate report medical input ICSR causality product safety