Sr Assoc Pharmacovigilance Operations Job at Amgen (Hyderabad)

Sr Assoc Pharmacovigilance Operations

Amgen

Location:
India , Hyderabad

Category:
-

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

Act as US/EU local safety office and FDA/EMA point of contact for safety reporting. Submission of all individual case safety reports to FDA/EMA/BPs. Support interactions with business partners (license partners) and vendors for all case intake and processing activities. Vendor oversight of all case processing activities and case quality including analysis and reporting of trends in quality measures. Ensure vendor compliance with approved processes and training requirements. Audit & external inspection support.

Job Responsibility:

Support reportable event reconciliation for Amgen sponsored clinical trials
Support vendor oversight of all case intake and processing activities
Case review
Escalation of case level issues
Support convention-related training delivery
Manage queries on Intake, triage, and data entry of ICSRs
Reporting decision for submitting all expedited safety reports to FDA/EMA
Ensuring that individual ICSRs are evaluated for reporting in compliance with regulations and contracts
Reporting of ICSRs within time frames determined by regulations and contracts
Support BP reconciliation as required by safety agreement
Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness
Be representative for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility
Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor

Requirements:

Bachelor’s degree and 2 years of directly related experience
Associate’s degree and 6 years of directly related experience
High school diploma / GED and 8 years of directly related experience
Understanding of global regulatory requirements for pharmacovigilance
Familiarity with clinical development process
Case processing experience with demonstrated high case level productivity and quality
Attention to detail
Proficiency in safety system
Microsoft Suite: Word, Excel, PowerPoint, Project, Outlook