Location:Redwood City, United StatesJob reference:
Nov. 12, 2016
Acerta Pharma was established in 2013 with a mission to discover and develop novel targeted molecules with the potential to improve patients' lives. At the core of our vision is a foundation based on cutting edge technologies, which enable the development of specific and selective drug candidates. Acerta's innovations translate to more effective and less toxic prospective therapies. As a member of the AstraZeneca group, Acerta is well positioned to rapidly achieve its first of hopefully several drug approvals to come.
The Sr. Associate, Medical Safety Operations role encompasses a key position in executing departmental strategy and the day-to-day functions of Medical Safety (MS) Operations. This role collaborates with colleagues and vendors including MS Science, MS Excellence, Clinical Science, Clinical Operations, Biometrics, Regulatory Affairs (RA), Quality Assurance (QA), and Legal.
The Sr. Associate, Medical Safety Operations is responsible for performing internal activities and overseeing outsourced activities for ICSR processing and reporting from all sources in compliance and quality according to company procedures and regulatory requirements. Ensuring that expedited and periodic safety reports to regulatory agencies and license partners are submitted and compliance is tracked. Liaise with assigned Clinical Reviewer to ensure that appropriate review and assessment is provided for ICSRs. The selected candidate will be responsible for safety data extraction and production from MS systems for internal partners and regulatory submissions. Performing receipt and submission reconciliation between license partners and vendors and serious adverse event (SAE) reconciliation between the clinical and safety databases. Will collaborate with QA on product complaints associated with ICSRs and supports regulatory agency interactions (both written and verbal), inspections, and audits.
* Safety database experience
* Detailed knowledge of relevant US, EU, and ICH guidelines, initiatives and regulations governing both clinical studies and post-approval safety
* Proficient in MS Word, Excel, PowerPoint, Outlook and other applicable business software tools
* Bachelor's degree in life sciences, MD, PhD, PharmD, BSN/RN
* Minimum 3 years of drug safety, clinical research, or healthcare related experience
* Argus database experience
* Minimum of 2 years direct pharmaceutical industry experience dealing with global clinical study safety processing and reporting preferred; post-approval safety experience
Next Steps -- Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.