Pharmacovigilance SOP and Training Associate - United States
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Under the leadership of the Senior Director, Pharmacovigilance (PhV) Quality, Compliance & Safety Systems, assists in the management of Procedural Documentation. This includes the development and revision of Global Pharmacovigilance relevant Standard Operations Procedures (SOPs), Working Instructions (WIs) and training materials and delivery of training in relationship to the SOPs and Work Instructions (WIs). The responsibilities includes in-depth knowledge of process documentation and ability to work with Functional Subject Matter Experts (SMEs) within the department to understand of the department’s process and procedures.
- In collaboration with the SMEs, develops, writes, and updates SOPs and WIs.
- Develops an in-depth knowledge of Global Pharmacovigilance processes, and acquires/possesses the necessary knowledge to develop and update procedures so that Pharmacovigilance’s operational and regulatory goals are met.
- Coordinates meetings for development and discussion of SOPs and WIs.
- Creates Job Aid and any other documents for departmental processes
- Manage and coordinate comments and review cycles timelines
- Help ensure the Drug Safety and Pharmacovigilance staff is updated on the most current domestic and international regulations relevant to a Drug Safety organization (new ICH steps, new FDA or international guidelines, etc.)
- Updates drug safety forms and templates in harmonization with relevant clinical operation forms and templates (i.e. Call Center form, SAE data collection form and CRF)
- Responsible for all IT aspects and training associated with the safety database.
- Actively participate in the development, implementation, maintenance and delivery of Drug Safety department training programs and initiatives including applicability matrix
- Maintains up-to-date tracking of SOP implementation, review and retirement dates.
- Ensures appropriate documents are stored in shared documentation systems when applicable.
- Assures that SOPs and WIs have the appropriate SME and Management review and do not conflict with other procedures or overall GCP, GPvP and GMP requirements
- Manage SOP, WI archival process for obsolete versions
- Evaluate processes for potential improvement in efficiency and effectiveness and recommend changes
- Participate in special projects to support departmental initiatives
- Perform other duties as assigned
- BA/BS with a minimum of 2 to 4 years of direct pharmacovigilance experience
- Experience in Biotech/Pharmaceutical industry required
- Understanding of drug safety processes, FDA and other national or international regulations, and ICH guidelines required
- In depth pharmacovigilance knowledge, meeting facilitation and procedural documentation writing skills required.
- Exercises independent judgment and identifies and implements methods, techniques, and evaluation of criteria to achieve results
- Contributes to successful completion of programs, projects, and/or functions
- Demonstrates strong analytical/problem-solving skills
- Possesses excellent business communication skills (oral and written)
- Demonstrates strong interpersonal/organizational skills as well as a team-oriented approach
- Possesses strong computer skills in pharmacovigilance applications, Microsoft Office Suite (Word, Excel, and PowerPoint)
- Applies attention to detail
- Practices good time management skills
- Possesses ability to work independently
- Must be comfortable in a fast-paced, demanding work environment
- Must be fluent in English
- Maintains high ethical standards, including a commitment to Incyte values and behaviors