Drug Safety Physician - Oncology

SystImmune; Princeton (NJ); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Comprehensive benefits

Job summary

SystImmune is seeking a Medical Safety Lead to oversee pharmacovigilance activities at our Princeton, NJ site. You will lead safety surveillance, assess signals, and help generate DSURs and other safety reports while coordinating with Medical Monitors and CROs.

The role requires MD degree with 5+ years in Drug Safety, strong regulatory knowledge for US/EU, and experience with safety assessments and risk management. Oncology/Hematology experience is preferred.

Qualifications

• 5+ years of Drug Safety/Pharmacovigilance experience in pharma/biotech, CRO, or regulatory bodies.
• Medical Degree (MD) from a recognized medical school with clinical practice experience; oncology/hematology preferred.
• Strong working knowledge of US and EU drug safety regulations (CIOMS, ICH).
• Proven experience in medical safety assessments, safety surveillance, and risk management.
• Experience with aggregate reports (DSUR, PSUR/PBRER, PADER) and regulatory filings.

Responsibilities

• Lead medical safety input and safety surveillance activities, identifying safety signals and ensuring timely communication.
• Contribute to generation of aggregate safety reports (DSURs, PADER, PBRER).
• Serve as leading medical safety resource for protocols, ICFs, IBs, and RSI review.
• Collaborate with Medical Monitors, CRSs, and vendor staff for ongoing trials.
• Support Risk Management Plans and updates, and SOPs/Guidance documents.
• Serve as subject matter expert for pharmacovigilance vendors and activities.
• Work with Product Safety Leads to respond to health authorities and audits.

Skills

Drug safety expertise

Regulatory knowledge

Medical safety assessment

Safety surveillance

Cross-functional collaboration

Education

MD or equivalent medical degree

Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

This individual is to lead medical assessment and interpretation of safety data from multiple sources, including clinical trials, and literature reports. The individual will be closely collaborating with cross functional teams in supporting all clinical development programs, regulatory filling, and global safety related activities. This individual will also support the clinical R&D team in the oversight of PV service vendors and partners and will need to maintain medical knowledge, as well as current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management practices.

This role requires a full-time onsite presence at our Princeton, NJ location.

Responsibilities

• Provide medical safety input and participate in safety surveillance activities (e.g., identification of safety signals and ensure timely assessment and communication of confirmed safety signals).
• Provide input in the generation of aggregate safety reports (e.g., DSURs, PADER, PBRER).
• Serve as a leading medical safety resource for the development and review of clinical trial protocols, informed consent forms (ICFs), investigator brochures (IBs) and Reference Safety Information (RSI).
• Collaborate with Medical Monitors and Clinical Research Scientists and vendor clinical staff as needed for ongoing clinical trials.
• Provide medical safety input in the development and/or updates of Risk Management Plans and the maintenance of these documents.
• Provide support and input to the development of Standard Operating Procedures, Working Instructions, and other guidance documents.
• Serve as a subject matter expert for vendors that provide drug safety and pharmacovigilance services.
• Work closely with other Product Safety Leads to respond to and resolve safety questions from health authorities as well as regulatory agency’s audits and inspections.

Qualifications

• 5+ years’ experience in Drug Safety/Pharmacovigilance in a pharmaceutical or biotech company, CRO or regulatory agency.
• Medical Degree (MD) from a recognized medical school with medical practice experience. Oncology / Hematology experience strongly preferred.
• Strong working knowledge of US and EU drug safety and pharmacovigilance regulations, CIOMS and ICH guidelines.
• Proven experience in medical safety assessments, safety surveillance and risk management activities.
• Proficiency with medical review of ICSDs, including expectedness assessments, causality assessments, narrative review and generation of Analysis of Similar Event and company comment statements, including benefit-risk assessment.
• Experience with preparation of aggregate reports (e.g., DSUR, PSUR/PBRER, PADER)
• Experience in preparation of responses to regulatory authorities; experience with regulatory filing and related activities preferred.

SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.

SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.