Affiliate Safety Representative

The Affiliate Safety Representative (ASR) is responsible to organize, implement, and maintain the Affiliate PV System. Ensures local processes and procedures are in place to define pharmacovigilance responsibilities within the Affiliate in line with Global SOPs and local regulations.
• Maintains a version-controlled training matrix. Ensures training of affiliate personnel and partner company staff is undertaken according to relevant SOPs, and that appropriate training records are maintained.
• Collection and reporting PV-relevant information and ICSRs in accordance with global and local procedures, reconciliation of PV-relevant information with Global PSRM, affiliate non-PV functions, commercial partners and service providers. Timely identification and appropriate response to incidences of noncompliance.
• Local implementation and tracking of activities in accordance with Risk Management Plans (RMPs).
• Ensures local language medical or scientific literature, not included in PSRM global literature review, are reviewed to identify possible adverse events, and that any reports are forwarded in a timely manner to GPV and local competent authority (as required).
• Archiving of local PV documents and maintain business continuity management for critical PV processes.
• Maintains awareness of local PV legislation. Ensures PSRM is notified of any important changes to relevant Local Legislation.
• Ensure the content of local pharmacovigilance agreements conforms to Mylan standards and local requirements.

Ever growing team with lots of perspective and potentional for the future

1 May 2018 (ostávajú ešte 7 dni)