Drug Safety Associate
Ambrx Inc., is a clinical-stage biopharmaceutical company focused on developing Precision Biologics using an expanded genetic code. Ambrx technology uses an expanded genetic code to incorporate synthetic amino acids into protein, all completed within a living cell. These synthetic amino acids enable the creation of Precision Biologics, an exciting new class of therapeutics with broad application and potential. This includes next-generation antibody drug conjugates (ADCs), bispecifics, and targeted immuno-oncology therapies for cancer as well as smart cytokines to modulate the immune system, and long-acting therapeutic peptides for metabolic and cardiovascular disease.
We are seeking a highly motivated, fast learning Drug Safety Associate. This role is responsible for providing drug safety team support and ensuring the quality documentation of safety data, particularly serious adverse events (SAEs) are accurate and complete. This role provides support for the management and archiving of SAE cases, ensuring compliance with global clinical safety and pharmacovigilance regulations and Drug Safety department procedures in all aspects of drug safety case processing and reporting. .
Job Requirements and Responsibilities:
- BS/BA life science degree with 2-3 years pharmacovigilance -related work experience or MS/PharmD with knowledge of pharmacovigilance
- Understanding medical /safety terminology
- Excellent attention to detail with focus on quality of work
- Strong general administration skills and experience, written and verbal and interpersonal skills
- Vendor management and timely invoice payment tracking
- Excellent organizational and prioritization skills
- Schedule safety management meetings and document minutes
- Develop and maintain organized safety filing systems and processes
- Provide administrative support to Drug safety team and Clinical Development team
- Flexible with ability to adapt to changes in organizational priorities and ambiguous environments
- Working knowledge of Microsoft Office suite of products, including Word, Excel, PowerPoint, etc.
- Knowledge of clinical trial processes and ICH/FDA guidelines is a plus
- Familiarity with ARGUS system and RAVE EDC system is a plus
To be considered as an applicant, please submit your resume/CV referencing the specific position of interest and position code. Applicants whose qualifications and experience most closely match the requirements of the position will be reviewed. Candidates will only be contacted for evaluative discussions. Ambrx offers competitive compensation & benefits.