Global Patient Safety Physician
1 day ago
We're seeking a highly skilled Global Patient Safety Physician to join our team at Lilly.
The purpose of this role is to perform medical roles within the Global Patient Safety Medical function, including providing global medical leadership and input into all aspects of safety for assigned products.
Key Responsibilities:
1. Product or Molecule Safety Physician / Lead Physician
a) Provide global medical leadership and input into all aspects of safety of assigned product(s), including surveillance programs and risk management planning.
b) 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
- Manage decisions and actions to be taken, including communication to appropriate customers (e.g., Product Teams, Management, Affiliates and Regulators)
- Liaise with GPS Medical Area Directors and with Lilly Medical Therapeutic Area Team Leaders and Directors, as appropriate, to fulfill safety obligations;
c) 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.
d) 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
e) 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 and 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
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.
Lilly is an equal opportunity employer and welcomes applications from diverse candidates.
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