Full-Time Senior Manager Pharmacovigilance

Senior Manager, Pharmacovigilance Operations encompasses a key leadership role in providing direction to the Pharmacovigilance department for adverse event case management, support of study teams and projects, oversight of maintenance of drug safety database, and collaboration to support risk management and pharmacovigilance for all Deciphera Pharmaceuticals Clinical Trials and post marketing (where applicable).

What You'll Do:

• Responsible for performing critical safety vendor oversight to ensure all pharmacovigilance activities are performed in an efficient, consistent and compliant manner
• Accountable for coordination of day-to-day operational ICSR activities
• Review incoming adverse events to determine action required
• Provide oversight and review of vendor case processing and submission activities
• Manage Vendor Oversight including tracking of KPIs, metrics and QC of SAE / ICSR cases
• Responsible for facilitation of training, including training GVP Modules and key relevant US & EMA safety-related Guidance documents
• Lead Deciphera Pharmaceuticals PV Operations in ensuring all safety reports received from all clinical trials are processed consistently and compliant
• Manage SAE / SUSAR reporting activities
• Oversee maintenance of an externally hosted electronic safety database
• Provide direct technical/data management support to ensure information entered and retrieved from the safety database is consistent, accurate and complete
• Performing and contributing to safety monitoring and signal detection activities
• Perform ad hoc analyses as required
• Support the oversight and management of global business partner safety data exchange agreements
• Communicates with partner companies and vendors regarding safety data
• Develop and maintain Medical Safety and Pharmacovigilance related documents
• Lead preparation of safety-related plans with partners and CROs
• Provide guidance and support to project teams
• Work cross functionally with Regulatory Affairs and Quality Assurance
• Assist as needed with the preparation and updates to Investigator Brochures, DSURs, Protocols, ICFs, IBs, CSRs, CCDS, RMP, REMS, etc.
• Assist with response to safety-related queries
• Assist with the ongoing review TFLs and AE data
• Support the development of Deciphera Pharmaceutical PV infrastructure
• Oversee deviation and CAPA activities
• Adhere to company policies and applicable regulations
• Other duties as assigned

What You'll Bring:

• Education: Bachelor's/Advanced degree preferably in life science, nursing, pharmacy, or other healthcare related profession
• Experience: 6+ years of direct pharmacovigilance work experience
• Skills: Experience with Argus Safety database, solid understanding of US and ex-US pharmacovigilance regulatory requirements, ICSR submission experience, knowledge of MedDRA and WHO Drug dictionaries, experience with overseeing and managing vendors, experience in pre- and post-approval pharmacovigilance activities, strong clinical knowledge, strong analytical ability to review, evaluate, interpret, and synthesize clinical and safety data

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