PV Associate III
· Responsible for receipt of safety information including, Serious Adverse Event (SAEs), Adverse Event (AE), and pregnancy reports from all sources.
· Performs initial Individual Case Safety Report (ICSR) processing activities, including determination of initial, follow-up, and duplicate reports.
· Responsible for initial data entry for ICSRs in the global safety database
· Manages department archiving in accordance with procedures
· Responsible for the receipt and triage of phone calls received via the general GPS phone number.
· Responsible for monitoring the GPS Inbox for receipt of safety information and reconciliation information
· Archives all relevant ICSR documentation per procedures.
· Performs Vendor/Business Partner ICSR reconciliations per procedures.
· Participates in internal process improvement teams and projects as directed by management.
· May assist with defined or routine activities related to due diligence and/or regulatory inspections.
· Must adhere to the requirements of regulatory authorities, ICH and GCP as applicable.
· Assists department members with special projects, as required.
· Performs ICSR reporting to Health Authorities/Regulatory Agencies and ICSR distribution to Vendor/Business Partner and other stakeholders as required.
· Performs other duties, as assigned.
· B.S. in a scientific or allied health field (or equivalent degree) and 0 – 3 years of relevant work experience in the Biotech or Pharmaceutical industry, or relevant comparable background
Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.
Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.
Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.
Role: PV Associate III
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