Officer- Pharmacovigilance- Quality & Literature Review

RESPONSIBILITIES

• Support the execution of Pharmacovigilance (PV) related activities at Unichem Laboratories Limited
• Review literature articles with respect to validity
• Perform literature screening and maintain records of literature searches
• Perform triage and booking in Argus Database
• Complete data entry in Argus Database on a need basis
• Conduct quality review in Argus Database
• Perform Eudravigilance ICSR screening
• Prepare, review, and submit aggregate reports (Periodic Adverse Drug Experience Reports PADERs) as requested by regulatory authorities
• Prepare and maintain PV documents, SOPs (Standard Operating Procedures), and WIs (Work Instructions)
• Train PV team and relevant stakeholders on SOPs and WIs
• Manage global submissions
• Provide oversight on all activities related to case processing
• Organize training for corporate office, manufacturing plants, and other vendors for new and existing employees
• Provide satisfactory responses to all PV-related queries
• Manage reconciliation activities between Unichem and QPPV, business partners, distributors, and marketing authorization holders
• Carry out other responsibilities assigned by Head PVD / Supervisor / Designee

DESIRED SKILLS

• Good knowledge about GVP (Good Pharmacovigilance Practices) modules and guidelines
• Basic knowledge of Computers
• Good Communication skills