Safety Physician (CONTRACT)

Precigen, Inc•Germantown, MD

About The Position

This is a contractor/1099 position for a Safety Physician. The role involves performing medical reviews of post-marketing adverse event reports, assessing causality and clinical relevance, and contributing to signal detection and benefit-risk assessments. The Safety Physician will also author and review health hazard assessments, support labeling updates, and collaborate with various internal teams and external regulatory authorities. The position requires a strong understanding of pharmacovigilance regulations and methodologies.

Requirements

MD/MBBS required.
Experience in post-marketing pharmacovigilance/drug safety.
Strong knowledge of FDA and EMA PV regulations
Strong knowledge of ICH E2 guidelines
Strong knowledge of Signal detection methodologies
Strong knowledge of Benefit-risk assessment
Strong knowledge of MedDRA

Nice To Haves

Oncology/rare disease/gene therapy experience
Experience with safety databases and signal detection tools

Responsibilities

Perform medical review of post-marketing ICSRs and spontaneous adverse event reports.
Evaluate the medical context, completeness, and clinical relevance of reported events.
Assess causality, seriousness, expectedness/listedness, and medical significance of safety cases.
Apply medical judgment in accordance with company procedures and global pharmacovigilance regulations.
Review and analyze literature safety cases and post-marketing safety data.
Identify clinically meaningful findings or potential emerging safety concerns.
Conduct signal detection, signal validation, and signal evaluation activities.
Review safety data trends from multiple sources to support proactive safety surveillance.
Identify emerging safety trends and potential risks associated with Papzimeos.
Escalate significant findings through appropriate safety governance processes.
Support benefit-risk assessment activities for Papzimeos.
Contribute medical input to ongoing evaluation of the product safety profile.
Review and provide medical input into PADERs, PSUR/PBRERs, and signal reports.
Ensure safety conclusions are medically accurate and scientifically justified.
Participate in signal management meetings and safety governance discussions.
Present medical assessment of safety signals and support cross-functional decision-making.
Provide medical assessment for special situation cases including pregnancy, medication errors, and product quality complaints associated with adverse events.
Determine potential safety implications and reporting requirements when applicable.
Author and medically review Health Hazard Assessments (HHAs) in response to Product Quality Complaints (PQCs), ensuring accurate evaluation of potential patient risk, clinical impact, and regulatory reporting requirements in alignment with applicable safety and pharmacovigilance standards.
Support safety labeling updates based on emerging safety data.
Provide medical rationale for proposed safety language changes in product labeling documents.
Provide medical input for Medical Information Call Center custom response preparation and review.
Ensure responses are medically accurate, consistent with approved labeling, and aligned with medical information requirements.
Collaborate with pharmacovigilance, regulatory affairs, medical affairs, and quality teams.
Support alignment of safety activities across cross-functional stakeholders.
Ensure compliance with global pharmacovigilance regulations, ICH guidelines, and internal SOPs.
Maintain high-quality and inspection-ready safety review practices.
Support responses to regulatory authority safety queries related to marketed products.
Provide medically sound and scientifically supported input for health authority communications.