Sr. Spclst, Drug Safety

Job Description

The Senior Specialist, PV-O&GPE collaborates with cross-functional colleagues to support operational regulatory pharmacovigilance (PV) company policies, processes, standards and software system configuration that impact individual case safety reports (ICSR), aggregate reports and downstream medical review and safety signaling activities. Maintains PV global standards for relevant activities to ensure compliance and quality aligned with SDLC (software development lifecycle), ICH/GCP and global PV requirements. The Senior Specialist stays current on existing and emerging SDLC, ICH/GCP and PV regulations and guidance.

Core Responsibilities

• Develop and maintain the necessary processes and training to ensure high quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations
• Participate in interdepartmental and cross-functional meetings to support operational and regula...