Drug Safety Associate (RE-12441377) South San Francisco, California
|Salary:||USD65000 - USD80000 per annum|
Drug Safety Associate
A pharmaceutical company in South San Francisco, CA is looking for a Drug Safety Associate to join their team. The company is a small oncology company with an exciting pipeline.
This is a full-time position for a Drug Safety Associate in the Clinical Operations group for overseeing and performing specific tasks related to serious adverse event processing and reporting for assigned investigational product. This individual may serve as a liaison to external contract safety providers and company personnel for safety issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs and Medical Affairs.
- Conducts complete initial clinical reviews of all domestic and foreign adverse event reports for all investigational products.
- Ensures consistency in the initial evaluation and assessment of serious adverse event reports and source documentation for completeness, accuracy and legibility
- Exercises judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness, expectedness and listedness.
- Generates appropriate queries to sites to complete and clarify SAE case information and exercises judgment in determining when cases are complete and ready to close.
- Drafts SAE narratives for assigned cases and updates narratives when follow-up information is received.
- Reviews all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and related documents.
- Prepares Medwatch, CIOMS, and other forms and other documents for reportable cases and works with internal and external personnel to make sure reporting is appropriately performed.
- Participates in preparation of safety sections for regulatory documents
- Participates in signal detection activities
- Supports Head of Safety to provide processing and reporting to licensing partners.
- Interacts on a regular basis with Clinical Project Mgrs, Regulatory, Medical Affairs, etc to identify process improvement strategies and communicate project status updates.
- Interacts on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues.
- Delivers monthly metrics to supervisor efficiently, accurately and within agreed-upon timelines
Drug Safety Associate Job Requirements:
- Bachelor's degree in nursing or pharmacy or in a health-care related field required.
- Minimum of two to four years drug safety experience in a biotechnology or pharmaceutical company.
- Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries.
- Familiarity with safety databases, data entry platforms, adverse event data collection process, case processing unit, call center, product complaints, 15-day safety alerts, submissions of safety updates to the regulatory bodies including FDA/EMA, Pharmacovigilance Safety Data Exchange Agreements, Risk Evaluation and Mitigation Strategies, Medications Guides, pre-approval process and post-marketing commitments to FDA, FDA Industry Guidelines, ICH Guidelines, Regulatory Approval Process and Drug Development.
- Knowledge of cGXPs
- Demonstrated Good Documentation Practices
- Must be proficient in MS Office Suite.
- At least one of the following: LPN, RN, RPh, PharmD, P.A.
- Excellent written and verbal communication skills.
- Fluent in medical terminology.
- Ability to interpret and follow regulatory guidelines.
- Ability to manage both day-to-day operations as well as project work in a fast paced environment.
- Ability to work both independently and in a collaborative team setting.
If you are interested in applying for this role, please reply to this job posting as soon as possible to be considered.