1+ months

Expanded Access Specialist

Pfizer
Wuhan
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**ROLE SUMMARY**

Pfizer's Expanded Access Program is within Global Operations, Governance and Community/Worldwide Medical and Safety/Worldwide Research, Development and Medical organizations. This program provides treatment options using an unauthorised medicine which, under strict conditions, can be made available to patients who have a life-threatening and serious illness, who have exhausted all treatment options and who are not eligible for a clinical trial. The medicine must have completed, at minimum, a Phase I Trial to determine safety and risk/benefit. The current program and processes follow GSOP-CT16 as well as the local laws and regulations.



The Expanded Access Specialist will provide transactional support for the different components of the Compassionate Access Program. Transactional support mainly includes the following areas:



+ **Safety-** Assist the global Expanded Access Lead and/or Sr. Expanded Access Request Managers (EARM) with the management of safety remediation by overseeing appropriate SAE reporting and safety report distribution in accordance with relevant Pfizer SOPs. Support the EARMs and Sr EARM with registration processes, Physician follow-up, monthly reporting, safety remediation, and monthly metrics.

+ **Re-supply** - Act as primary point of contact for Expanded Access re-supply requests globally for an asset/medicine across the Pfizer portfolio, agnostic of therapeutic area and support the Lead EARM per product by fulfilling re-supply requests for active treating physicians.

+ **Data entry-** Support the Expanded Access Team with data entry reconciliations for safety, regulatory documentation, PfizerCAREs outlook mailbox needs, and PfizerCAReS portal entries.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Medical
Posted: 2020-09-03 Expires: 2020-11-05
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Expanded Access Specialist

Pfizer
Wuhan

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