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Search for Jobs by David Wright

Pharmaceutical Drug Safety Assistant - SF Bay Area (Science & Biotech)
San Francisco, CA 94101
Recruited by: David Wright | Recruiter | DOCS See all my Jobs

  • Hiring Company: DOCS
  • Industry: Science & Biotech
  • Compensation: Salary: 40K to 55K
  • Expires: Dec 06, 2019
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Job Description

PLEASE DO NOT APPLY FOR THIS POSITION IF YOU ARE NOT LOCATED IN THE SF BAY AREA.

We have a very well established pharmaceutical client located by SFO airport and looking for people to work in Pharmacovigilance/Drug Safety in drug safety intake.

Primary Responsibilities:

• Inbox Management and Case Receipt
• Case Registration and Confirmation
• Case Follow-Up

Inbox Management and Case Receipt

The Service Provider will be required to monitor the company Inbox for case intake, and ensure all emails are triaged and actioned appropriately (tracked, forwarded, assigned to an alternate case processing team, acknowledged, archived). The Service Provider will forward emails to relevant stakeholders as per agreed conventions and ensure timely escalation of urgent communications to the company as appropriate. The company will also access and monitor the mailbox as required. The company utilizes SPARC platform for Inbox management.

The Service Provider will receive ICSR cases and/or source documents via digital sources (i.e., E2B, Gateway transmission, LAM) or non-digital routes in order to initiate case processing activities. A non-digital route is defined as ICSRs received via email, fax, postal mail, etc.

Most information to be received by the Service Provider is anticipated to be in English. If the Service Provider receives documents that are not in English, they must alert the company to co-ordinate the translation.

Case receipt activities include but not limited to the following responsibilities:

The Service Provider will electronically track all cases and source documents received to ensure information to be captured is not missed and the appropriate Day 0 is recorded
The Service Provider will verify in accordance with company Procedure Documents for the accuracy and completeness of all source documents received
The Service Provider will ensure the minimum information is present for all cases as identified in company Procedure Documents

Case Registration and Confirmation

Case registration activities include but not limited to the following responsibilities:

For all ICSRs received, identify and query critical missing information to register the case (e.g. country of reporter or occurrence, missing clock start date, missing company product)
Perform a duplicate check to determine if a report is duplicate, initial or follow up to an existing report
If non-valid due to the missing valid case criteria, the report should still be registered in the Global Safety Database
Complete case registration in accordance with applicable with company Procedure Documents
The Service Provider will register all cases in the Global Safety Database within 2 business days of receipt
The Service Provider will confirm case receipt/acknowledgement (based on company SOPs and/or Process Documents) for digital and non-digital cases.

Case Follow-Up

Case follow up activities include but not limited to the following responsibilities:

The Service Provider will request additional information to cases followed up by the company if an assessment is deemed necessary for medical evaluation of the case outside of standard queries
The Service Provider will assist with follow-up activities based on medical review queries in accordance with company Procedure Documents
Perform follow-up for all applicable cases and document in the Global Safety Database in accordance with company Procedure Documents
Monitor and review outstanding follow-up query action items for applicable cases within the Global Safety Database
The method of querying will be in accordance with company Procedure Documents. This may include fax, email or electronically through Global Safety Database, if applicable/available


DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.