Medical safety Physician

Investigo; Princeton (NJ); On-site; USD 180,000 - 240,000; Full time

Job summary

Confidential biopharmaceutical company in Princeton, NJ is seeking a Drug Safety Physician to lead medical assessment of safety data across development programs.

MD with 5+ years in pharmacovigilance; responsibilities include safety surveillance, ICSRs causality, DSUR/PSUR/PBRER reporting, regulatory interactions, and risk management.

Qualifications

• MD required with medical degree from a recognized school.
• 5+ years in Drug Safety, Pharmacovigilance or Medical Safety.
• Experience with ICSRs, including causality, narrative review and risk assessment.
• Knowledge of US/EU pharmacovigilance regulations (CIOMS, ICH).
• Oncology/hematology experience preferred.

Responsibilities

• Provide medical safety input and ongoing safety surveillance.
• Lead medical assessment of individual case safety reports (ICSRs).
• Contribute to aggregate safety reports (DSURs, PSURs, PBRERs).
• Support risk management plans and regulatory interactions.
• Collaborate with cross-functional teams (Regulatory, Clinical).

Skills

Pharmacovigilance

ICSR assessment

Regulatory submissions

Cross-functional collaboration

DSUR/PSUR/PBRER reporting

Global pharmacovigilance regs

Oncology experience

Education

Medical Degree (MD) from a recognized medical school

Job description

Confidential Search | Princeton, NJ | Full-Time | Onsite

A well-funded, clinical-stage biopharmaceutical company is seeking a Drug Safety Physician to support the medical assessment and interpretation of safety data across multiple clinical development programs.

This is an opportunity to join a growing biotech organization working across innovative oncology therapeutics and contribute directly to the company's clinical development and global drug safety activities.

The Drug Safety Physician will serve as a key medical safety resource across clinical development, pharmacovigilance, regulatory and cross-functional teams. The role will have meaningful involvement in safety surveillance, medical review of individual case safety reports, signal evaluation, risk management, aggregate safety reporting and regulatory activities.

What You'll Do

• Provide medical safety input and participate in ongoing safety surveillance activities, including identification and assessment of potential safety signals.
• Perform and oversee medical assessment of individual case safety reports, including causality, expectedness, narrative review and company comment assessments.
• Contribute to aggregate safety reports including DSURs, PADERs and PBRERs/PSURs.
• Provide medical safety input into clinical trial protocols, informed consent forms, investigator brochures and Reference Safety Information.
• Partner closely with Medical Monitors, Clinical Research, Regulatory and other cross-functional teams supporting ongoing clinical trials.
• Support development and maintenance of Risk Management Plans.
• Provide input into SOPs, working instructions and pharmacovigilance guidance.
• Serve as a medical safety subject matter expert for external pharmacovigilance vendors and partners.
• Support responses to health authority questions and regulatory inspections/audits.
• Maintain current knowledge of global pharmacovigilance regulations, safety surveillance practices and risk-management requirements.

What We're Looking For

• Medical Degree (MD) from a recognized medical school.
• 5+ years of experience in Drug Safety, Pharmacovigilance or Medical Safety within pharmaceutical, biotechnology, CRO or regulatory environments.
• Medical practice experience.
• Strong experience with medical assessment of ICSRs, including causality, expectedness, narrative review and benefit-risk assessment.
• Experience with safety surveillance, signal assessment and risk management activities.
• Experience contributing to aggregate safety reports such as DSURs, PSURs/PBRERs and PADERs.
• Working knowledge of US and EU pharmacovigilance regulations, CIOMS and ICH guidelines.
• Experience supporting regulatory submissions or responses to health authorities is strongly preferred.
• Strong cross-functional communication and collaboration skills.
• Oncology or hematology experience is strongly preferred.
• Ability to work full-time onsite in Princeton, NJ.

Compensation

Actual compensation will be determined based on experience, qualifications and skills.

The company offers a comprehensive benefits package including fully paid employee medical, dental and vision premiums, short- and long-term disability coverage, a 401(k) with company matching, PTO, paid holidays and additional benefits.

This is a confidential search. Company information will be shared with qualified candidates during the interview process.

We are an equal opportunity employer and welcome qualified candidates from diverse backgrounds.