Location: Bengaluru, India
Primary Responsibilities
- Apply clinical judgement, critical thinking, and regulatory knowledge to the management of adverse event data within GPS systems to ensure data integrity, consistency, and compliance.
- Continuously expand knowledge of company compounds / products (e.g., design of clinical trials, safety profile, regulatory commitments, indications, identified risks, main adverse reactions, risk minimization activities).
- Continuously expand regulatory expertise on case collection and expedited reporting requirements dictated by major regulatory agencies (e.g., FDA, EMA, MHRA, PMDA).
- Participates as a cross functional team member of study teams, as assigned
- Understand functioning of systems owned GPS (e.g., MOSAIC, LSS), contributing with updates / enhancements and solution of workflow issues
- Process adverse events and other safety information from various sources (e.g., Clinical Trials, Patient Support Programs, company Market Research, literature, spontaneous reports, etc.).
- Assess individual reports identifying gaps of information and the need to conduct follow-up to clarify seriousness, expectedness, causality and achieve case completion.
- Comply with internal and external timelines for managing adverse event data entry.
- Lead/support literature search strategy updates and system issues/enhancements.
- Translate global / regional / local PhV regulatory requirements into expedited reporting rules and conduct Product License studies activities.
- Responsible for the completeness and accuracy of data management within the GPS Systems, and other associated case management activities. These activities may include but are not limited to:
- Management of adverse events arising from various sources including but not limited to literature, Patient Support Programs (PSPs), Clinical Trials (CT), spontaneous, pregnancy, devices, company Market Research (LMR), etc.
- Ensure the following: appropriate serious outcome criteria for adverse events are selected, appropriate terms selected from source documents, listedness and relatedness is completed accurately, and cases are available as appropriate for Medical Review.
Minimum Qualification Requirements:
- Master’s degree or equivalent experience. Healthcare degree, or study in the area of pharmaceutical/biological science preferred.
- Critical thinking to solve problems, and make decisions autonomously, and as part of a team.
- Ability to apply critical thinking and flexibility in the use of electronic systems and adapting new and changing systems.
- Basic computer skills (i.e., word processing, tables and graphics, spreadsheets, presentations, templates, databases, search engines).
- Ability to work effectively in a global team and apply understanding of diversity and inclusion.
- Fluency in English (write / read / speak)