Associate Medical Advisor

2 weeks ago

Bengaluru, India Lilly Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The purpose of the GPS Senior Medical Advisor/ Medical Advisor is to perform medical roles within the Global Patient Safety (GPS) Medical function. These include performing as the Product or Molecule Safety Physician/Lead Physician, training/coaching /mentoring and demonstrating Global Patient Safety expertise. He or she is the Eli Lilly & Co. GPS Medical Area 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.

**Key Responsibilities **_(includes and not limited to)_**:
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; 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;
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
- Represent Global Patient Safety

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