What are the responsibilities and job description for the Pharmacovigilance Specialist position at MW Partner?
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.
