Full-Time Senior Manager, Pharmacovigilance Operations

Senior Manager, Pharmacovigilance Operations encompasses a key leadership role providing direction to the Pharmacovigilance department.

Responsibilities include:

• Overseeing adverse event case management.
• Supporting study teams and projects.
• Maintaining drug safety databases.
• Collaborating on risk management and pharmacovigilance for all Deciphera Pharmaceuticals Clinical Trials and post marketing activities (where applicable).
• Ensuring efficient, consistent, and compliant pharmacovigilance activities from vendors, managing vendor oversight.
• Reviewing incoming adverse events and determining required actions.
• Overseeing and reviewing vendor case processing.
• Managing Vendor Oversight, including tracking KPIs, metrics, and quality control of SAE/ICSR cases.
• Facilitating training of GVP Modules and relevant US & EMA safety-related Guidance documents and procedures.
• Leading Deciphera Pharmaceuticals PV Operations to ensure compliant processing of all safety reports.
• Managing SAE/SUSAR reporting.
• Overseeing maintenance of an electronic safety database.
• Providing technical/data management support for safety database.
• Performing safety monitoring and signal detection activities.
• Performing ad hoc analyses as needed.
• Supporting oversight and management of global business partner safety data exchange agreements/pharmacovigilance agreements.
• Communicating with partners and vendors regarding safety data exchange.
• Developing and maintaining safety documents (e.g., Safety Management Plans, SOPs).
• Providing guidance and support to project teams in safety-related areas.
• Working cross-functionally with Regulatory Affairs and Quality Assurance.
• Contributing to safety sections of clinical study reports.
• Assisting with Investigator Brochures, DSURs, Protocols, ICFs, IBs, CSRs, CCDS, RMP, REMS etc.
• Assisting with response to safety-related queries.
• Supporting regulatory submission activities, signal detection and management, and responses to health authority inquiries.
• Supporting the development of Deciphera Pharmaceutical PV infrastructure.
• Overseeing deviation and CAPA activities.
• Adhering to company policies and regulations.
• Other duties as assigned.

Qualifications:

• Bachelor's/Advanced degree in life sciences, nursing, pharmacy, or related field.
• 6+ years of direct pharmacovigilance experience.
• Argus Safety database experience.
• Strong understanding of US and ex-US pharmacovigilance regulations.
• ICSR submission experience preferred.
• Knowledge of MedDRA and WHO Drug dictionaries.
• Vendor management experience.
• Pre- and post-approval pharmacovigilance experience.
• Strong analytical, communication, and problem-solving skills.
• Proficiency in standard computer software.

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