Drug Safety Pharmacovigilance Document Manager - 22-134
Fully Remote
Job Type
Full-time
Description

Seeking an experienced and energetic person to manage, evaluate, and file drug safety pharmacovigilance (DSPV) documents using the eCTD format. Experience working with document sharing software for the purpose of time sensitive submissions of safety reports to the IRBs (institutional review boards), IECs (independent ethics committees) and PIs (principal investigators). This is a remote-based position.

  

Responsibilities: 

· Perform review of documents within the DSPV mailbox for format, completeness, review, and filing 

· Coordinate with other document managers within other functional groups to assure consistent document filing practices

· In collaboration with the DSPV team and document management team, evaluate and manage DSPV documents for filing within the Veeva Vault and/or SharePoint repository. 

· Responsible for reviewing, organizing, and filing information from ongoing clinical and post marketing safety reports.

· Continuous assessment and review of documents being sent to the central DSPV mailbox for filing

· Develop SOPs for the management of document filing and document sharing software (SharePoint, Intralinks, psiXchange, etc.)

· Assist in scheduling safety meetings and creation of meeting minutes

· Interfaces with functional areas within and outside of PV (clin ops, regulatory, data management, medical affairs, corporate partners, and preferred vendors)

Requirements

 

· 2-3+ years of pharmaceutical, biotech or CRO experience with basic understanding of drug development

· Minimum of 2 years’ experience in drug safety pharmacovigilance department within a CRO or biotech or pharmaceutical company 

· Comprehensive understanding of DSPV documents and forms used in clinical trials 

· Familiar with the eCTD structure and content

· Proficient with Veeva Vault Systems and SharePoint

· Comprehensive experience with safety letter exchange programs such as psiXchange or Intralinks

· Basic understanding of global regulatory requirements for safety letter submissions

· Excellent organization skills and ability to prioritize individual and teamwork loads

· Excellent written and oral communication skills 

· Experience in working within clinical trials and post marketing is a plus

· Ability to utilize Word, Excel, and PowerPoint software