Job description

Our client, a Biopharmaceutical company, is looking for a Sr. Assoc Pharmacovigilance Operations for their Remote location.

Responsibilities:

Supports the safety surveillance process for client products by performing daily manual report review and follow up activities with patients and HCPs of individual case safety reports.
To support the safety surveillance process for client products by performing follow up activities with patients and HCPs of individual case safety reports.
Ensure vendor compliance with approved processes and training requirements.
Oversee case quality of US ICSRs (CT and PM) including analysis and reporting of trends in quality measures.
Point of accountability for managing one or more key vendor relationships for ICSR processing.
Case processing point of contact for case related activities with assigned business partners.
Case processing point of contact for audit related activities related to case processing.
Accountable for measuring quality against contractual safety agreements.
Accountable FDA point of contact for ICSR reporting. Submission of all individual safety reports to FDA, EMA and Business Partners.
Case review / QC. Escalation of case level quality issues.
Support convention-related training delivery.
Supporting the reporting of Adverse Event Case Reports to FDA/EMA/Business Partners within time frames determined by regulations and contracts.
Perform daily manual report review.

Requirements:

Understanding of global regulatory requirements for pharmacovigilance.
Familiarity with clinical development processes .
Case processing experience. Attention to detail.
Competence in life cycle safety systems and medical coding.
Comprehensive English writing skills.
Excellent phone conversations skills.
Comprehensive knowledge on MS Office applications.
Key Relationships :Case Management vendors, GQM/BPO, SOPS, MSRT, LSOs, Business Partners.
(Basic) Bachelor's degree and 2 years of directly related experience OR Associate's degree and 6 years of directly related experience
Employee Value Proposition: Career growth, opportunity, industry experience, networking

Why Should You Apply?

Sr. Assoc Pharmacovigilance Operations

Role overview