Pharmacovigilance Specialist Job at MW Partner, Los Angeles, CA

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  • MW Partner
  • Los Angeles, CA

Job Description

MW Partners is currently seeking a Pharmacovigilance Specialist to work for our client who is a global leader in the pharmaceutical industry.

Responsibilities and duties:

  • Management of Adverse Events including activities such as processing adverse event case reports and conducts followup
  • 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 Client 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 selfinspection 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.

Requirements :

  • Looking for someone with a background in Pharmacovigilance who can follow international regulatory guidelines.
  • Preference is for the ARGUS database.
  • PSUR exp would be nice.

For a confidential discussion or to find out more contact Snehita onor apply now.

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