Manager, Drug Safety & Pharmacovigilance Operations (Remote) - 23-210

The Manager, Drug Safety & Pharmacovigilance (DSPV) Operations will assist with management and oversight of the DSPV Vendor on a day-to-day basis, ensuring that DSPV activities are managed in compliance with local regulations and company policies/procedures at a local, regional, and global level and in accordance with any DSPV agreements with business partners. This role will report directly to the Director, DSPV Operations within the Drug Safety and Pharmacovigilance (DSPV) department and provide process-related expertise for the various project specific activities including but not limited to processing of Individual Case Safety Reports, Regulatory operations, and communicate with his/her reporting manager/DSPV Vendor for queries/feedback as applicable. This is a remote-based position located in the United States.

Responsibilities:

• Responsible for setting up a collaborative working relationship with suppliers and vendors to ensure regulatory requirements as well as contract oversight
• Ensure that processes are followed by third party vendors, by implementing quality and compliance oversight with case management DSPV processes and regulatory submission activities
• Ensure requirements for Service Level Agreements and achievement of all defined and agreed Key Performance Indicators in terms of quality, compliance and trainings are met with DSPV Vendor
• Provide functional expertise/oversight of process and handling queries of the DSPV Vendor
• Monitor group mailboxes utilized for the centralization of process and specific inquiries
• Ensure that appropriate management monitoring plans are in place (Safety Management Plans, Quality Management Plans, Communication Plans) for vendor case processing safety information while meeting regulatory compliance with authorities and DSPV principles worldwide
• Participate in meetings with DSPV Vendor, Internal study team, DSPV department, and interdepartmental as needed
• Ensure inspection readiness by maintaining compliance with applicable SOPs, regulations and guidelines with the Regulatory agencies
• Support and participate in internal/external audits/inspections, also, supports with CAPA and remediation of process/training needs
• Support with follow up actions from findings for safety related activities
• Maintain up-to-date knowledge of basic relevant regulations and the Company’s Standard Operating Procedures
• Contribute to the development of internal SOPs related to Drug Safety and pharmacovigilance
• Support with Call Center reconciliations and oversight of safety related reports
• Support with Regulatory submission

• Bachelor’s degree with 8 years or Master’s degree with 6 year’s experience in a life science/healthcare/pharmaceutical-related field. Proven emerging management experience demonstrating business acumen, exposure to developing and delivering functional/department goals, delivering results, challenging current practices to drive improvement and innovation, coaching and developing subordinates through sharing knowledge/experience including remote and cross-functional teams
• 5+ years working within Drug Safety/Pharmacovigilance; 3+ in safety database management
• Oncology experience is preferred
• Excellent understanding of Argus and capability of supporting data migration is a must
• Good knowledge on clinical and post-marketing (DSPV) domains
• Experience in drafting/reviewing safety related plans and documents (SMPs, SAE report forms, post-marketed report forms, reconciliation plans, etc.)
• Close attention to detail and ability to be flexible in order to meet daily competing priorities of the business
• Ability to collaborate with a team and be self-motivated
• Excellent interpersonal and time management skills
• Excellent verbal and written communication skills
• Ability to demonstrate Elevar’s core values by holding ourselves and each other accountable for the work we do, taking time to collaborate effectively while working remotely, making space for ingenuity in work and thought, and staying grounded in compassion

The anticipated annual base salary range for this role is $110,000 to $150,000. Final compensation depends on multiple factors including but not limited to, relevant experience, skillset, depth and breadth of knowledge, internal equity, and external market factors. Elevar Therapeutics is a rapidly growing biotech company that offers competitive wages and benefits package including medical, dental, vision, time off, a retirement plan, and other voluntary benefits for employees.

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