Job Details

  • Title: Drug Safety Associate
  • Code: RCI-54230
  • Location: Horsham Pennsylvania (PA) 19044
  • Posted Date: 05/21/2020
  • Duration: 11 Months
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  Job Description

Bring Your Own Device (BYOD)/Laptop
POSITION SUMMARY:
Responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.

PRINCIPAL RESPONSIBILITIES:
75-80%
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


5%
Processes and 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

5-10%
Project work: participation in assigned projects, including inspection/audit readiness activities
Participation in local or global project teams, including on-time delivery of assigned responsibilities
Participation in inspections and audits as identified, including interviews and provision of requested data
Personal development: continuous development of personal skills whether task or competency-related. Activities may include project involvement, technical training, shadowing and/or mentoring others, soft-skill development.

5%
Perform other related duties as required
Mentoring of other DSAs or staff, as identified
Maintains compliance with company guidelines and HR Policies