Senior Manager, Drug Safety Clinical and Post-marketing Operations

Position Overview:The Senior Manager, Drug Safety Clinical and Post-marketing Operations will lead the management of the pharmacovigilance (PV) vendor on a day to say basis, ensuring that pharmacovigilance and risk management activities are managed in compliance with local regulations and company policies/procedures at a local, regional, and global level and in accordance with any agreements with business partners. This role with report directly to the Senior Manager, Drug Safety Operations & Compliance and the Drug Safety department and provide process-related expertise, support, and direction for pre- and post-marketing safety related activities. Key Responsibility Areas:

• Pharmacovigilance Leadership: Back-up to the Senior Manager, Drug Safety Operations & Compliance.  Lead pharmacovigilance vendor management oversight activities performed by contract research organizations to ensure compliance with regulatory requirements are being met. Oversee and manage pharmacovigilance activities related to Clinical Trials and Post-marketing activities/requirements. Manage pharmacovigilance agreements with the PV vendor and business partners to ensure compliance is being carried out .

Specific Responsibilities:Responsibilities include, but are not limited to:

• Lead pharmacovigilance vendor management oversight activities including day-to-day oversight, review, and evaluation of the vendor performance and quality.
• Monitor Key Performance Indicators/ compliance metrics from the pharmacovigilance vendor and monitor for trends or possible improvements.
• Final review of PADER narratives and oversight of submission compliance.
• Develop, execute, and manage Business Partner Agreements, Agreements with PV vendors (i.e. Master Service Agreements, Statement of Work, Change Orders), and other agreements necessary to maintain PV compliance with commitments made and regulatory requirements.
• Oversee and monitor reconciliation performed by PV vendor and Business Partners for accuracy and compliance with business agreements.
• Oversee/manage pharmacovigilance activities related to clinical trials & post-marketing commitments.
• Develop, execute, and manage Clinical, Post-marketing, Safety Management, Investigator-Initiated Study Plans in respects to pharmacovigilance activities in coordination with management.
• Ensure clinical trial and post-marketing case reporting processes are efficient and compliant with regulatory reporting requirements & reporting requirements detailed in the applicable plan/ agreement (i.e. safety management plans (SMP) / PV agreements).
• Provides guidance to PV vendor on technical aspects of clinical trials and post-marketing activities/commitments, including configuration of the Global Safety Database and relevant reporting rules, as applicable.
• Ensure all safety reports received from clinical trials are processed in a consistent and compliance manner.
• Manage SAE/SUSAR reporting activities for all investigational drugs, as applicable.
• Contribute to the preparation of relevant safety sections of: Clinical Study Reports, Annual Reports, Investigator Brochures, Protocols, ICFs, Risk Management Plans, and other regulatory filing documents, as needed.
• Provide responses to Regulatory Agencies’ questions and requests concerning safety/pharmacovigilance activities.
• Serve as a Subject Matter Expert in internal and external pharmacovigilance audits performed by business partners and inspections by regulatory authorities to ensure that questions and matters are adequately addressed.

• Assist in auditing CROs, PV vendors, and business partners who manage and handle Pharmacovigilance responsibilities.
• Keep informed of global new safety regulations, guidance, and policy from the relevant regulatory authorities and notify organization of upcoming changes and status.
• Assist in the development or revision of SOPs, working procedures, guidance documents and safety management plans (SMP) governing Pharmacovigilance functions, as applicable.

• Other pharmacovigilance related functions assigned.

 Key Competencies/Requirements:

• Accountability:  Assumes responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others.
• Agility:  Responds positively to change, embracing and using new practices or values to accomplish goals and solve problems.
• Creativity:  Explores and advances opportunities to develop novel solutions and approaches to the improvement of processes and services.
• Empowerment:  Finds opportunities to improve and extend contributions to the organization and teammates.
• Integrity:  Demonstrates the highest commitment to integrity and shows respect for and values all individuals for their diverse backgrounds,