1. Product or Molecule Safety Physician / Lead Physician

• Provide global medical leadership and input into all aspects of safety of assigned product(s) 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 and clarification activities and risk evaluation activities; provide support, training and continued improvement as appropriate
  • Manage decisions and actions to be taken, including communication to appropriate customers  (e.g., Product Teams, Management, Affiliates and Regulators) and
  • Liaise with GPS Medical Area Directors  and with Lilly Medical Therapeutic Area Team Leaders and Directors, as appropriate, to fulfill safety obligations
• 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 Patient Labeling Committee and/or the Safety Review Committee as appropriate.
• Build collaborative working relationships with other Global Patient Safety 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 GPS Medical and/or Product on appropriate committees/product development and brand teams.
  • Provide medical support for Global Patient Safety activities and reports within the department, as appropriate.
  • Provide Global Patient Safety expertise to internal customers (e.g., regulatory, early phase development, 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 laws, regulations and  guidance.

2. Understanding and Support of the QPPV role

• Understanding the roles and responsibilities of the European Union Qualified Person (QPPV) and ensure their involvement in the pharmacovigilance system and processes.
• Ensure support and information are provided to enable the QPPV to fulfill all the QPPV legal responsibilities.

3. Training, Coaching, Mentoring

• Provide training, coaching and mentorship to safety surveillance scientists, and other GPS Medical physicians and clinical research scientists with respect to medical aspects of safety surveillance
• Provide Global Patient Safety training for development and brand team physicians and clinical research scientists and other audiences (e.g. Regulatory, Lilly Medical) as appropriate.
• Maintain compliance with Lilly Red Book and corporate policies, Lilly Research Laboratories and Global Patient Safety curriculum map.
• Maintaining compliance with the Lilly Corporate Integrity Agreement.

4. Global Patient Safety Leadership

Provide input to Global Patient Safety Leadership Team and Safety Review Committee as required; actively contribute to the management of Global Patient Safety at strategic level.

5. Provide ad-hoc involvement in operations, if required. 

6. Act as the Lilly GPS Medical Representative for both internal and external customers, interacting as  prescribed in corporate guidelines and policies

• Build strong relationships with key customers, representing and championing the role of safety in the organization:
  • Product Team Leaders and Business Unit Leadership
  • Regulatory
  • Affiliate Medical Directors/Clinical Research Physicians
  • COE and  Discovery and Clinical Research
  • External opinion leaders
• Represent Global Patient Safety within the company and externally; and Review and comment on external regulatory policy and trends affecting Global Patient Safety.

7. A GPS Senior Medical Advisor/ Medical Advisor CRP is expected to meet the criteria as outlined in the global path job criteria for the R4(Medical Advisor) and R5 (Senior Medical Advisor levels.

For each level on every global path, there are a consistent set of job criteria which includes functional and technical expertise, decision making, influence, and problem solving.