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PV Specialist
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• Safety Risk Management Activities
o Implement risk minimization activities locally as required. (GVP Module V)
o Identify, escalate and communicate all relevant local critical safety issues/ signals. (GVP Module IX)
• PV Quality Systems
o Have a thorough understanding of and comply with the Baxter Pharmacovigilance Quality systems and policies.
o Maintain expert knowledge and awareness of local pharmacovigilance regulations and implement as appropriate.
o Ensure adequate understanding of audit and inspection preparation and readiness.
o Ensure understanding of the Nonconformance (NCR) and CAPA (Corrective and Preventative Actions) process. Responsible for performing CAPA activities as per identified roles.
o Ensure compliance with procedures for document management retention and archiving.
o Understand and implement the document change management process and act as SME (Subject Matter Expert) for local procedures
o Ensure all training requirements for the role are met.
o Identify appropriate stake holders and ensure they are trained on PV reporting requirements/ procedures.
• Case Intake
o Manage the receipt and capture process for adverse event (AE) and pregnancy report collection in the Pharmacovigilance safety database
o Assess the need for utilizing appropriate forms and questionnaires, complete appropriate forms and capture the information in the Pharmacovigilance safety database.
o Perform the initial assessment on case validity, check for core case elements, perform duplicate checks and request for case deletion as required.
o Perform a seriousness assessment and assess expectedness against the local label.
o Perform translation of source documents and local quality check of translation as required. Ensure all source documents are captured in the Pharmacovigilance safety database.
• Regulatory Submissions
o Maintain expert knowledge of the regulatory reporting requirements and ensure the reporting rules in the system are aligned to the local reporting requirements.
o Manage the process for expedited submission of AEs to local authorities with translation of documents as required. Track submissions in the Pharmacovigilance safety database and archive all submission records.
o Respond to submission related queries from the local regulatory authorities and archive all regulatory related correspondence.
• Other Responsibilities
o Perform local medical and scientific literature surveillance; detect and report AEs from local literature.
o Provide the appropriate local inputs for the PSMF (Pharmacovigilance Systems Master File) sections.
o Maintain a local calendar for any specific local regulatory report requirements (e.g., AE line listings). Request the required information from the Global team and submit the reports to authorities as per regulatory requirements.
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Education and Experience
-Bachelor degree or higher in medicine, pharmacy, nurse, veterinary, medical science or an equivalent degree in a scientific field
-Minimum 1+ year’ experience in Pharmaceutical industry.
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