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 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 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 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.

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 on 909-206-2714 or apply now.

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