Clinical Safety Manager

Job Overview:

Provides safety expertise to clinical development programs. Performs pharmacovigilance with rapid identification and analysis of safety signals to define emerging drug safety profiles of products and drive patient risk management.

Key Accountabilities:

The role of the Clinical Safety Manager is to contribute to effective and efficient proactive safety strategies for the assigned processes and delivery of operational safety aspects. This includes the provision of key expertise and guidance to concerned Global Patient Safety functions and other functions within the company, as well as vendors for safety operational tasks.

In addition, the Clinical Safety Manager is accountable for developing, optimizing, implementing, and documenting appropriate processes to ensure Pharmacovigilance compliance in the area of responsibility. Define process KPIs, implement, monitor, and communicate performance and develop solutions for continuous improvements.

Ensures sponsor's required compliance by vendors involved in clinical trials and non-interventional post authorization studies in close collaboration with the Vendor Manager.

The Clinical Safety Manager is responsible and accountable for the following:

• Clinical Safety Management
• Standard operating procedure (SOPs), Working Instructions (WI) reviews, inputs, knowledge, and understanding
• Informed Consent Form (ICF), review and input for safety-related sections.
• Protocol review
• Safety Management Plan Ownership
• Reference Safety Information (RSI) Maintenance
• Investigator-sponsored studies (ISS) agreement review
• Request for proposals and Vendor Selection
• Contribute to defining and implementing of clinical trial safety-related activities in the Alliance with relevant partners/service providers of sponsor's Healthcare and alignment of guidelines and processes related to clinical trial safety management with existing GPS processes
• Responsible for Safety Management Plan, including review and oversight
• SMC/DMC Coordination of activities and oversight
• Act as an SME for the COMPASS database
• Contribute to the improvement of routine PV activities throughout the process lifecycle

Qualifications:

• Work experience in healthcare, pharmacovigilance area, clinical development and clinical research is an advantage (required)
• Secondary Education degree is an advantage or relevant professional experience equal to scientific studies
• Minimum 6 years of professional experience in Drug Safety of Clinical Trials and Sound understanding of worldwide regulations relevant to the safety of drugs in development and post-authorization
• Excellent communication skills in an international environment
• Intercultural experience through successful collaboration in matrix teams
• Ability to work in an intense, fast-paced, matrix-ed, multinational work environment. Strong oral and written communication skills
• Fluent in the English language (written and spoken); a 3rd language is an asset
• Ability to effectively communicate with employees, colleagues, and global counterparts'
• Positive motivator
• Team worker
• Customer and result orientation

Cooperation:

Interface with other internal departments/functions

• GPS Operations functions, especially Vendor Manager and Case Processing
• All Global Patient Safety internal groups, including LPSSs and Medical Safety
• Local Data Entry sites
• Quality Assurance
• Medical Affairs
• Clinical Operations

External interfaces:

• CROs/Vendor
• Clinical trial investigators
• Business/development partners

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at https://jobs.iqvia.com