Associate Pharmacovigilance Analyst
Core
Ensures GVP Module VI compliance, manages Adverse Event Reporting Systems (AERS), and supports pharmacovigilance requirements for primary market research projects.
Role type
Associate Pharmacovigilance Analyst
Builds
Adverse Event Reporting System (AERS) processes and client PV compliance frameworks
Domain
Healthcare / Life Sciences / Pharmacovigilance
Deliverable
client delivery
Required skills
GVP Module VI compliance, Adverse Event Reporting System (AERS) administration, CAPA creation and management, contract negotiation support, PV data monitoring and reporting
Preferred skills
Primary market research (PMR) familiarity, Quality Management Systems (QMS) knowledge
Technologies
Adverse Event Reporting System (AERS)
Responsibilities
Ensure GVP Module VI compliance on specific projects, maintain internal PV training, administer and improve the Adverse Event Reporting System (AERS), create and ensure completion of CAPAs for PV reporting issues, check client PV Agreements for compliance, respond to client queries and complaints
Seniority
Associate, entry-level to mid-level