Senior Manager Drug Safety Operations

I am partnered with a reputable Biotech focused on the discovery, development, and commercialization of new medicines to treat cancer. It specializes in small molecule therapies that target key signaling pathways involved in cancer cell growth and survival. The organization is known for its commitment to advancing precision medicine and has developed several FDA-approved therapies.

They are hiring for a new Safety position which a key role in overseeing safety-related vendor operations for clinical trials and contributes to the effective management and optimization of case processing within the Argus Safety Database. The role ensures alignment with international pharmacovigilance (PV) standards and internal safety protocols throughout all aspects of case handling and reporting.

Key Responsibilities:

• Handle serious and non-serious adverse event reports from initial receipt to finalization in the Argus system, including narrative creation, MedDRA coding, and query resolution.
• Apply rigorous quality standards to case reviews, ensuring accurate and thorough safety documentation, in collaboration with medical safety personnel.
• Provide training to new team members on safety systems and case processing workflows.
• Work cross-functionally with departments such as Clinical Development, Operations, Data Management, and Regulatory Affairs to ensure proper safety data flow and integration.
• Lead safety-related activities for clinical studies, including reviewing study documents, contributing to regulatory submissions, and developing safety management plans and documentation templates.
• Oversee external partners and CROs to ensure compliance with safety protocols and contractual obligations.
• Coordinate with Data Management to perform reconciliation of safety data as per study-specific plans.
• Contribute to the development and refinement of standard operating procedures and best practices for safety operations.
• Manage individual workload effectively to support departmental objectives.
• Perform additional tasks as needed.

Qualifications:

Education and Experience:

• Bachelor's degree in a relevant field with at least 9 years of experience, or
• Master's degree with a minimum of 7 years of experience, or
• Doctorate with at least 2 years of relevant experience, or
• Equivalent education and experience combination.
• Professional certification may be required depending on the role.

Preferred Background:

• Clinical or pharmaceutical degree (e.g., Nursing, Pharmacy) with substantial clinical experience.
• Prior work in the biotech or pharmaceutical industry, especially in oncology.
• Familiarity with Argus Safety Database and adverse event processing in both clinical trial and post-marketing settings.

Skills and Competencies:

• Solid understanding of industry practices and regulatory requirements related to drug safety.
• Strong analytical skills and attention to detail in documentation and problem-solving.
• Effective time management and ability to work independently.
• Clear communication skills, both written and verbal.
• Collaborative mindset with the ability to engage stakeholders and resolve differing viewpoints.
• Willingness to mentor junior staff and continuously develop professional knowledge.
• Proficiency in business communication and data interpretation.