Sr Assoc Pharmacovigilance Operations

Purpose:

To support the safety surveillance process for clients 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.
Support conventionrelated training delivery.
Supporting the reporting of Adverse Event Case Reports to FDA/EMA/Business Partners within time frames determined by regulations and contracts.
Case review / QC. Escalation of case level quality issues.
Perform daily manual report review.

Understanding of global regulatory requirements for pharmacovigilance.
Familiarity with clinical development processes .
Case processing experience. Attention to detail.
Competence in Argus 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

Education & Experience (Basic)
Bachelors degree and 2 years of directly related experience OR associate degree and 6 years of directly related experience

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