Manager, Global Drug Safety & Pharmacovigilance

Job Title

This position is primarily responsible for providing management level oversight, planning and execution of post-marketing and clinical trial safety activities ensuring compliance, quality, inspection readiness and operational excellence. The incumbent in this position also serves as a safety liaison with the Company's cross-functional teams, license partners and the contract safety organizations responsible for global drug safety and pharmacovigilance.

The base compensation range for this role is $120-130K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

Summary Of Key Responsibilities

• Serve as resource and contact for other functions within the company for pharmacovigilance operational activities
• Responsible for overall vendor performance and vendor service outputs (delivered timely and on budget) including, but not limited to:
• Oversight of US AE call center;
• Oversight of adverse event processing by outsourced vendor, including the review and monitoring of compliance through various monitoring reports / KPIs;
• Participation in quality audits of individual case safety reports (ICSR) following vendor processing, with a specific focus on accuracy of narrative to reflect source documentation, MedDRA coding, expectedness against RSIs and appropriateness of queries to seek follow-up from the clinical sites / reporter;
• Oversight of adverse event reconciliation between safety and clinical databases, and adverse events exchanged between licensing partners;
• Review of safety-related section of aggregate reports (DSUR, PSUR/PBRER, PADER, RMP);
• Review and approval of pharmacovigilance related documents submitted to the Trial Master File (TMF);
• Provision of vendor project specific training;
• Collaboration with vendors to develop Safety Management Plans (SMP) and relevant forms and templates;
• Collaboration with vendors to develop process-related documents for the purposes of improvement and standardization of new processes; and
• Maintaining knowledge of safety systems (Argus experience preferred);
• Assist in creating and maintaining standard operating procedures and working practices to ensure inspection readiness and compliance with regulations and guidelines;
• Support internal / external audits and regulatory inspections;
• Assist in management of pharmacovigilance vendor contracts and forecasting activities;
• Assist in management of license partner safety data exchange agreements (SDEA);
• Assist management in establishing and coordinating all product safety operations functions in accordance with regulations and the Company's policies and procedures;
• Assist in preparation and review of regulatory submissions, such as safety reports and aggregate / periodic reports;
• Represent the Company in product safety meetings with its cross-functional teams, license partners and contract safety organization;
• Provide training to Company personnel and third parties for pharmacovigilance requirements and compliance;
• Maintain current knowledge of regulations and regulatory guidelines, particularly in the US, Europe and Japan.

Required Qualifications And Skills

• Bachelor's degree in life sciences, nursing, pharmacy, or related healthcare profession with relevant experience
• At least 5 years of pharmaceutical industry drug safety and pharmacovigilance experience involving development and post-marketed products
• Solid vendor management or CRO pharmacovigilance project management experience, including safety management plan preparation, establishment of KPIs / metrics, and contract management
• Strong knowledge of ICSR processing and the adverse event lifecycle
• Solid experience with drug safety databases, especially with Argus; data migration experience preferred
• Ability to independently identify, analyze, and solve complex operational and data?related issues
• Strong understanding of current pharmacovigilance practices and global pharmacovigilance regulations, including regulatory reporting requirements
• Self-motivated, detail-oriented, with the ability to prioritize and plan effectively
• Excellent written and verbal communication skills
• Ability to work both independently and within a matrixed team in a dynamic, fast-paced environment with shifting priorities
• Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and Adobe Pro

Travel Requirements: Approximately 10%