AstraZeneca Pharmaceuticals LP

TITLE: Senior Patient Safety Specialist

LOCATION: Wilmington, DE; Remote work may be permitted within a commutable distance from the worksite in accordance with internal policy.

HOURS: Full-time/ Mon-Fri / 40 hrs/week

DUTIES: 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.

REQUIREMENTS: Must possess a Bachelor or foreign equivalent in Pharmacology or a related field plus three (3) years of experience in the role offered, as a Clinical Researcher or in a related role within the healthcare or pharmaceutical industry. Must have at least three (3) years of experience with all the following in the pharmaceutical and/or drug development industry: Compliance Monitoring, trending Analysis, CAPA Investigations, audit and inspection and readiness, writing SSI for Study protocols, QC of various processes related to patient safety, project management, product launch activities, Safety agreements termination and review, and writing SSI for Study protocols.

AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

Click Apply to submit your application. No calls please. EOE.