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Principal Medical Officer
1 month ago
As a Principal Medical Officer - Pharmacovigilance Expert at ScaleneWorks, you will be responsible for signal detection and evaluation activities for assigned products. Your tasks will include ensuring the accuracy of evaluation documents and providing clear conclusions in response to internal or regulatory authority requests for safety data. You will also assist in the production of Risk Management Plans (RMPs) and regulatory periodic reports. Additionally, you will be part of a process improvement initiative team and complete post-audit/inspection activities.
Requirements
Your Medical Doctor (physician) degree or equivalent, along with additional relevant medical or scientific post-graduate qualifications, will be essential for this role. You should have relevant experience in pharmacovigilance or drug development and pharmacovigilance experience relating to Safety Evaluation and Risk Management. Knowledge of international pharmacovigilance requirements and drug development and approval processes is also necessary.
Additional Responsibilities
You will build effective working relationships and respond to the needs of line functions in the matrix. You will support safety governance/SRTs and establish and operate cross-functional teams to detect and address product safety issues. You will also mentor junior colleagues and contribute to evaluating their activities.
