ZRP35 Drug Safety Physician

ZRP35 Drug Safety Physician

15 Nov
|
PAREXEL International Ltd
|
Ajitgarh

15 Nov

PAREXEL International Ltd

Ajitgarh

Job Description



Reviewing ICSRs for even selection, MedDRA coding, causality, seriousness, expectedness, narrative cohesiveness and providing medical assessment comment in accordance with client requirements/conventions and Standard Operating Procedures (SOPs)

Communicating/discussing issues related to the review process with the Team Lead

Identification and timely communication of potential safety signals and/or safety concerns from reviewed single case reports to the client

Maintaining excellent knowledge of the safety profile of the assigned products, client procedures and international drug safety regulations



Maintaining an awareness of global regulatory requirements and reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines

Interacting with internal or external contacts to resolve issues related to the review process

Identifying areas of concern within the team and raising the issues with the Team Lead

Providing support for audits and inspections; involved in inspection readiness activities, as required. QualificationsMBBS, MD

The original job offer can be found in Kit Job:
https://www.kitjob.in/job/19966672/zrp35-drug-safety-physician-ajitgarh/?utm_source=html

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