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.

• 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.

Job Tags

Similar Jobs