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Senior Safety Scientist
1 month ago
Position Overview
The (Sr.) Safety Scientist is a critical member of the Pharmacovigilance & Drug Safety team who will support the risk assessment and characterization of the Company’s investigational product. The successful candidate is expected to be equally effective working independently as well as collaboratively with cross-functional stakeholders. The individual must possess clinical knowledge and analytical skills to ensure that safety data analyses and signal assessment reports are of high quality and in adherence to PV industry standards and regulatory timelines. Accountability in leading and managing projects as well as ability to analyze, interpret, and effectively communicate safety data is a key success factor for this role.
Responsibilities
- Serve as the Safety Lead at the study team meetings for the assigned investigational product
- Responsible for review of aggregate safety data and signal management, including signal detection, signal investigation, and preparation of signal evaluation reports, including input into a design of a comprehensive safety surveillance system.
- Establish Safety Surveillance Team (SST) and develop associated procedures (e.g, Charter)
- Lead the SST and develop meeting materials (agenda, minutes, slide preparation)
- Medical review of Individual Case Safety Reports (ICSRs) for regulatory/expedited reporting
- Create and maintain reference safety information (RSI) in IB, company core data sheet, label (W&P)
- Review, contribute, and author sections of study protocol, ICF, IB, and other study specific documents to ensure alignment with benefit-risk profile
- Lead preparation of aggregate safety reports (e.g., DSURs) from kick-off to submission to applicable health authorities
- Support Risk Management Plan (RMP) related activities in preparation for MAH approval.
- Participate in regulatory submission activities (NDA, MAA) and support ad-hoc query responses to health authorities.
Qualifications
- MD, PharmD, PhD or equivalent
- Minimum 3-5 years experience in Pharmacovigilance/Drug Safety pharmaceutical experience
- Excellent verbal and written communication skills.
- Attention to detail and ability to think critically required
- Familiarity with case processing, expedited reporting rules, and safety database
Company Overview
Bicara Therapeutics is a clinical-stage biotechnology company developing first-in-class biologics engineered to bring together the precision of targeted therapy and the power of tumor modulators. The company’s bifunctional antibodies are designed to deliver an immunomodulatory payload directly to the tumor microenvironment to ramp up immune cell activity, potentially offering long-lasting efficacy. Bicara’s lead asset, BCA101, a first-in-class EGFR / TGF-β-trap bifunctional antibody, is currently enrolling patients in a Phase 1/1b study. Bicara’s experienced team brings deep expertise across immunology, oncology, clinical development, business development and operational strategy. More information is available at .
Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.
Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
To apply, please email your resume/CV to careers@bicara.com. In the subject line include your name and the job title.
