Alphanumeric Systems

Director

• Lead safety review and risk management activities for assigned products
• Evaluate safety data from clinical trials, post-marketing sources, and scientific literature
• Support global regulatory submissions and health authority interactions
• Draft and review responses to Health Authority Requests for Information (RFIs)
• Provide protocol, safety, and regulatory support to clinical development teams
• Participate in cross-functional safety governance and risk management activities
• Identify emerging safety concerns and recommend appropriate actions
• Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies
• Provide scientific leadership in product safety evaluation, benefit-risk management, and pharmacovigilance across clinical development and post-marketing programs
• Independently manage safety issues and contribute to strategic safety decision-making across global programs

Scientific Director – SERM, Clinical Safety, Pharmacovigilance

Medical Director

• Lead safety evaluation and benefit-risk assessments for assigned products
• Support pharmacovigilance and risk management activities across clinical development and marketed products
• Contribute to regulatory submissions and health authority interactions
• Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs)
• Analyze and interpret clinical and safety data to support regulatory and business decisions
• Participate in cross-functional safety governance and product safety discussions
• Provide protocol and regulatory support throughout the development lifecycle
• Escalate significant safety concerns and emerging risks when appropriate

Medical Director, SERM, Clinical Safety, Pharmacovigilance

• Lead safety evaluation and benefit-risk assessments for assigned products
• Support pharmacovigilance and risk management activities across clinical development and marketed products
• Contribute to regulatory submissions and health authority interactions
• Prepare and review scientifically sound responses to Health Authority Requests for Information (RFIs)
• Analyze and interpret clinical and safety data to support regulatory and business decisions
• Participate in cross-functional safety governance and product safety discussions
• Provide protocol and regulatory support throughout the development lifecycle
• Escalate significant safety concerns and emerging risks when appropriate
• Provide medical leadership for safety evaluation, benefit-risk assessment, and risk management of products in clinical development and post-marketing settings

Medical Director – Clinical Safety & Pharmacovigilance

• Provide scientific leadership in the evaluation of product safety, benefit-risk management, and pharmacovigilance activities across clinical development and post-marketing programs
• Lead safety review and risk management activities for assigned products
• Evaluate safety data from clinical trials, post-marketing sources, and scientific literature
• Support global regulatory submissions and health authority interactions
• Draft and review responses to Health Authority Requests for Information (RFIs)
• Provide protocol, safety, and regulatory support to clinical development teams
• Participate in cross-functional safety governance and risk management activities
• Identify emerging safety concerns and recommend appropriate actions
• Collaborate with internal stakeholders to ensure scientifically sound and compliant safety strategies

Scientific Director – SERM, Clinical Safety, Pharmacovigilance

Medical Director, SERM, Clinical Safety, Pharmacovigilance

Medical Director – Clinical Safety & Pharmacovigilance

Scientific Director – Clinical Safety, Pharmacovigilance