Alliance Management Principal (Drug Safety) at Roche Diagnostics Limited
England, London - England, United Kingdom -
Full Time


Start Date

Immediate

Expiry Date

16 Dec, 26

Salary

65000.0

Posted On

17 Sep, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Industry

Hospitals & Health Systems

Description

·        Lead end-to-end pharmacovigilance operations, ensuring timely processing and submission of Individual Case Safety Reports (ICSRs) in alignment with global regulatory timelines and client-specific requirements.

·        Oversee daily case management activities, including case allocation, team capacity planning, resource prioritisation, workflow monitoring, and safety database oversight using Argus.

·        Ensure adverse event reporting compliance with global pharmacovigilance regulations and guidelines, including ICH, GVP, FDA, EMA, and applicable regional reporting requirements.

·        Drive operational delivery governance by monitoring SLA adherence, turnaround times, productivity, quality metrics, and escalation trends across PV workflows.


Responsibilities

·        Lead end-to-end pharmacovigilance operations, ensuring timely processing and submission of Individual Case Safety Reports (ICSRs) in alignment with global regulatory timelines and client-specific requirements.

·        Oversee daily case management activities, including case allocation, team capacity planning, resource prioritisation, workflow monitoring, and safety database oversight using Argus.

·        Ensure adverse event reporting compliance with global pharmacovigilance regulations and guidelines, including ICH, GVP, FDA, EMA, and applicable regional reporting requirements.

·        Drive operational delivery governance by monitoring SLA adherence, turnaround times, productivity, quality metrics, and escalation trends across PV workflows.


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