Description:
The purpose of the Clinical Research Physician, GPS Medical role is to perform medical roles within the Global Patient Safety (GPS) function. These include performing as the Product or Molecule Safety Physician/Lead Physician, training /coaching /mentoring and demonstrating Global Patient Safety expertise and leadership. He or she is the Company GPS Medical representative for both internal and external customers regarding a product or molecule, interacting as prescribed in corporate guidelines, standards and policies. Individualized responsibilities for a particular product or project will be discussed and agreed at an individual level.
Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
Product Lead Safety Physician / Lead Safety Physician
- Provide GPS Medical leadership and input into all aspects of safety of assigned compounds and products including surveillance programs and risk management planning.
- Ensure proactive safety surveillance:
- Lead risk management activities for assigned products globally
- Lead and guide the surveillance activities of scientists on the team including signal detection clarification and risk evaluation activities; provide support, training and continued improvement as appropriate
- Manage safety signal decisions and actions to be taken, including communication to appropriate “customers” (e.g., Development and Brand team, Management, Affiliates, Regulators, COE, Discovery and Clinical Research and Business Units)
- Liaise with GPS Medical team members and leadership, and development and brand team members, as appropriate, to fulfil safety obligations.
- Escalate appropriately patient safety issues and provide critical information on those issues to GPS Medical leadership.
- Supervise and review reports on safety issues and their implications for the Core Safety Information and Core Risk Minimization Activities.
- Represent PV position to Global Products Labelling Committee and/or the Safety Review Committee as appropriate.
- Build collaborative working relationships with other GPS Medical physicians and development and brand teams medical globally to ensure full cooperation and high-quality medical evaluation of safety data for global regulatory purposes.
- Represent the therapeutic area and/or product on appropriate committees/product development and brand teams.
- Provide medical support for Global Patient Safety Medical activities and reports within the department, as appropriate.
- Provide Global Patient Safety expertise to internal customers (e.g., regulatory, discovery and clinical research, business units).
- Provide medical input for review of adverse event cases.
- Lead process and provide medical input for review of suspected adverse reactions.
- Demonstrate knowledge in pharmacovigilance and risk minimization, which includes understanding of relevant aspects of the regulatory industry and scientific environments, laws, regulations and guidance.