Pharmacovigilance Specialist Job at Planet Group, Remote

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  • Planet Group
  • Remote

Job Description

Summary:

  • Provides operational support for global pharmacovigilance activities of marketed products.
  • Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines.
  • Responsible for data review, compilation, and analysis, including management of the integrated safety database.
Primary responsibilities for the role:
  • Management of Adverse Events including activities such as processing adverse event case reports and conducts follow-up .
  • Notifies regulatory agencies and business partners accordingly; responds to requests from regulatory agencies .
  • Reviews scientific literature and bibliographic sources; draft and manage periodic safety update reports.
  • Evaluates safety profiles; draft and manage signal detection reports; ensures document filing and archiving.
  • Participation in the processes of involving the collection, processing, review and distribution of adverse event information regarding development and marketed pharmaceutical products.
  • Contributes to ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with concerned departments, affiliates, distributors or business partners
  • Take part in self-inspection visits, audits, inspections and in CAPAs management, create or update pharmacovigilance procedures and working practices
  • Provide training to concerned persons based on the training plan and managing training documentation; archive documents according to prevailing standards
  • Support in the procedures of global pharmacovigilance operations such as Standard Operation Procedures (SOPs), internal business practices or working instructions.
  • Serves in an advisory capacity including activities such as product monographs review, draft responses to pharmacovigilance requests from regulatory agencies; participates in the drafting and implementation of pharmacovigilance contracts and agreements.

Pay Rate Range: $30-50/hr depending on experience 

Job Tags

Remote job, Contract work,

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