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Pharmacovigilance-Client of TASCoutsourcing

Talent Asset Software and Consulting

3 - 8 years Dubai - United Arab Emirates

Any Graduation. Any Nationality


, Posted on April 4, 2018 1 Opening

Job Description

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• Support the Gulf Oncology POP Champions in all activities related to POPs.
• Assist local associates to ensure appropriate training is undertaken, and clear roles and responsibilities are observed, prior to implementation of POPs.
• Ensure appropriate implementation and training on relevant Global/local SOPs as required.
• Work with local stack holders and POP governance board (if needed) to properly assess all potential activities whether or not in scope of POPs also to agree on the proper classification of the new programs with the proper archive and documentation.
• Ensure accurate & timely data entry into POPsys and local documentation is maintained as described in POP SOPs.
• Advise MPOs and other stakeholders on how to run POPs in compliance with applicable SOPs and required standards.
• If requested and needed assist with Vendor Selection Process, Supplier Quality Assessment, Contractual arrangements in respect of AE reporting, Vendor training and SDV, as described in applicable SOPs.
• Conduct and Support the initiation and monitoring (ongoing and close out monitoring activities) for ongoing POPs owned mainly by Drug Safety.
• Process all cases originating from POPs in Gulf and Levant on Argus Affiliate according to the applicable time frames and applicable processing conventions.
• Ensure documentations for all activities are archived according to the applicable SOPs, internal quality standards and external regulations


Industry Type : Pharma / Biotech / Clinical Research
Functional Area : R&D / Research & Development

Keywords

Pharmacovigilance

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Talent Asset Software and Consulting

www.tascoutsourcing.com

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Rhea - Rhea

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