at AstraZeneca Pharmaceuticals LP in Wilmington, Delaware, United States
Job Description
Lead pharmacovigilance activities on individual or cross-functional project related basis. Ensure compliance with global and local procedures, policies, and guidelines. Lead pharmacovigilance outsourcing activities through identification, selection, negotiation, and management/maintenance of current Good Pharmacovigilance Practices (cGVP). Lead quality review of data, reports and regulatory submissions. Lead triage process and data entry, follow-up requests for information from consumers and health care professionals. Serve as a Medical and Safety resource for the synthesis, analysis, evaluation and reporting of adverse event information. Provides case handling and safety support t licensing agreements, clinical study agreements and special projects. SME in pharmacovigilance related activities to patient safety staff. Leads US PS Operation vendor management and provides strategical oversight of external vendors.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
