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Drug Safety Associate

Ampcus Inc. Horsham Contractor
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Recruiting for Multiple locations - Horsham, PA / Malvern, PA / West Chester, PA / Raritan, NJ / Titusville, NJ

Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness 
Triage of incoming cases to prioritize for daily workflow management 
Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval 
Preparation of SUA summary: Analysis of Similar Events 
Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated. 
Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing 
Other activities relating to case processing as appropriate per case, including but not limited to: 
Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy 

Processes & procedures: awareness of and input to company procedures and guidance 
Completion of all assigned training on company and GMSO procedural documents relating to case processing 
Completion of training relating to relevant PV Agreements for assigned products 
Participate in designated activities to support revision/creation of case processing procedural documents

Recruiting for Multiple locations - Horsham, PA / Malvern, PA / West Chester, PA / Raritan, NJ / Titusville, NJ

Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness 
Triage of incoming cases to prioritize for daily workflow management 
Completion of remaining case data entry (including narrative or auto-narrative), manual coding, label and approval 
Preparation of SUA summary: Analysis of Similar Events 
Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated. 
Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing 
Other activities relating to case processing as appropriate per case, including but not limited to: 
Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy 

Processes & procedures: awareness of and input to company procedures and guidance 
Completion of all assigned training on company and GMSO procedural documents relating to case processing 
Completion of training relating to relevant PV Agreements for assigned products 
Participate in designated activities to support revision/creation of case processing procedural documents

Skills required

Chemical Engineering
Chemistry
Biotechnology
Environmental Science
Biology
Biochemistry
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Ampcus Inc., headquartered in Chantilly, Virginia is certified by SBA, USPAACC, WBENC. VMSDC as a leading 8(a), Minority and Women owned Professional services and Staff Augmentation firm. Our repeat business rate with our various clients has been remarkable and the extension of contracts with various clients stands testimony to our high commitment levels. Ampcus is proud of our high employee retention rate thereby ensuring that the work performed at our various client sites is smooth and efficient at all times.

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