Sr. Assoc Pharmacovigilance Operations

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?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities