Advisor/Senior Advisor-Medical Review

3 weeks ago


Bengaluru, India Lilly Full time

We’re looking for people who are determined to make life better for people around the world.

Key Responsibilities for Global Patient Safety (GPS) Medical Review

1.Medical support of individual case adverse event and product complaint reporting process

Provide the medical and clinical expertise necessary to support case managers and call center staff involved in receiving, preparing and reporting adverse events and product complaints Provide medical technical expertise in evaluation of adverse events, supporting the case management staff in ensuring appropriate follow-up, reviewing assessments providing review for the medical content of Individual Case Safety Reports (ICSRs) as needed To successfully meet these requirements, the Global medical reviewer associate medical advisor will work closely with the GPS Medical - therapeutic area and early phase medicine group physicians and Clinical Research Scientists (CRSs) and Safety Surveillance Teams (SSTs) to ensure appropriate communication of safety issues (both locally and globally), the medical quality of ICSRs and participation in the global assessment of the benefit: risk balance of Lilly products Identify or help support evaluation of potential quality issues with Lilly products that may adversely affect patient safety Assist in supporting customer response activities associated with adverse events/product complaints Provide review of the medical content of ICSRs that require medical review including the determination of the sponsor's assessment of relatedness for ICSRs that require this assessment.

2.Regional GPS Medical Leadership

As a medical representative of GPS for spontaneously reported and clinical trial individual case safety reporting in the Americas Regional Center, contribute to the global assessment of safety of Lilly products and molecules in clinical trials by interacting directly with the GPS Medical - therapeutic area and early phase medicine group physicians and CRSs; and SSTs involved in assessing the safety profile of Lilly products. This responsibility requires regular participation (in person or by teleconference) in relevant GPS global scientific and surveillance meetings related to management of marketed product and developmental product safety. Assist safety surveillance teams in review of specific individual ICSRs, bringing clusters of ICSRs from clinical trials suggesting a safety signal to the attention of SSTs, understanding Case Management specific issues and regulatory constraints, and conveying to the remainder of the Global Medical Review Group compound or trial specific issues and concerns. Build collaborative working relationships with other Physicians and Scientists in GPS Medical as well as Development and Brand Teams globally to ensure full cooperation and high quality medical evaluation of safety data for Global Regulatory purposes Participate in process development, quality review, continuous inspection and audit preparedness and inspection/ audit support, and similar activities in response to a changing regulatory environment or corporate priorities. 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

3.Understanding and support of the QPPV role

Have an understanding of the roles and responsibility of the European Union Qualified Person for Pharmacovigilance (QPPV) Ensure support is provided to enable the QPPV to fulfill the QP legal responsibilities

4.Other job expectations

Maintenance of medical expertise in areas of interest or specialty is expected. Understand and comply with all compliance policies, laws, regulations, the Red Book and the Corporate Integrity Agreement. Understand the confidential nature of company information and take necessary steps to ensure its protection. Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties.

Minimum requirements:

i) Bachelor's/Master's medical degree (MBBS/MD) from reputed institution.

ii) Good clinical experience of handling patients is preferred.

iii) At least 3-5 years of pharmaceutical industry experience, preferably in pharmacovigilance (medical review of individual case safety reports and related activities)

iv) Strong written, spoken, and presentation communication skills

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly



  • Bengaluru, India Lilly Full time

    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...


  • Bengaluru, India Recruise India Consulting Pvt Ltd Full time

    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...


  • Bengaluru, India Novo Nordisk Full time

    Global Medical Advisor **Category**:Medical Affairs**Location**:Bangalore, Karnataka, IN**Department** - Regions and Operations (Medical Affairs)- **The Position** - As a Global Medical Advisor, you will assist closely in providing strategic and medical guidance covering portfolio of products and functionally be a part of IO SO Medical affairs team....


  • 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...


  • Bengaluru, India Novo Nordisk Full time

    **Department - Regions and Operations (Medical Affairs)** **The position** As a Global Medical Advisor, you will assist closely in providing strategic and medical guidance covering portfolio of products and functionally be a part of IO SO Medical affairs team. Furthermore, you will be working on medical education and guidance materials across therapy...


  • Bengaluru, Karnataka, 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 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...


  • Bengaluru, India Novo Nordisk AS Full time

    Department : Global Medical Affairs. Are you a proven leader who can set direction and drive team performance? Do you have expertise in driving medical affairs strategy and tactics across therapeutic areas with a focus on diabetes, obesity and cardiometabolic portfolio? Then we might have the right position for you. We are looking for a Global Medical...

  • Medical Advisor

    3 weeks ago


    Bengaluru, India Novo Nordisk Full time

    The position As a Medical Advisor, you will contribute actively to devise and implement the medical affairs strategy in the country, be a specialist in the therapy area and allotted product/portfolio. You will be responsible to – Devise strategies and planning for launch of new indication/ products including KOL engagement and medical education....

  • Medical Advisor

    3 weeks ago


    Bengaluru, India Novo Nordisk Full time

    The position As a Medical Advisor, you will contribute actively to devise and implement the medical affairs strategy in the country, be a specialist in the therapy area and allotted product/portfolio. You will be responsible to – Devise strategies and planning for launch of new indication/ products including KOL engagement and medical education....

  • Medical Advisor

    2 days ago


    Bengaluru, India Novo Nordisk AS Full time

    Therapy Area – Rare Disease Location - Bangalore Are you an experienced medical professional and passionate about Medical Affairs? Does being part of a growing, yet dynamic environment excite you? Are you adept in implementing the medical affairs strategy in the country? If yes, then you may be the one we are looking for as Medical Advisor for...


  • Bengaluru, India Novo Nordisk Full time

       Department : Global Medical Affairs. Are you a proven leader who can set direction and drive team performance? Do you have expertise in driving medical affairs strategy and tactics across therapeutic areas with a focus on diabetes, obesity and cardiometabolic portfolio? Then we might have the right position for you. We are looking for a Global Medical...


  • Bengaluru, India Novo Nordisk Full time

       Department : Global Medical Affairs. Are you a proven leader who can set direction and drive team performance? Do you have expertise in driving medical affairs strategy and tactics across therapeutic areas with a focus on diabetes, obesity and cardiometabolic portfolio? Then we might have the right position for you. We are looking for a Global Medical...


  • Bengaluru, India Novo Nordisk AS Full time

    Department – Global Medical Affairs - Global Business Services (GMA-GBS). Are you a life science/research graduate interested in medical writing? Do you enjoy collaborating with peers in the medical field, interpreting and communicating scientific data? Does interacting with global medical leaders interest you? Then we have an opportunity for you...

  • Medical Advisor

    2 days ago


    Bengaluru, India Novo Nordisk AS Full time

    Therapy Area - Modern Insulin / New Generation Insulin (Diabetes Care) Location - Bangalore Are you an experienced medical professional and passionate about Medical Affairs? Does being part of a growing, yet dynamic environment excite you? Are you adept in implementing the medical affairs strategy in the country? If yes, then you may be the one we...


  • Bengaluru, India Novo Nordisk Full time

    Associate Global Scientific Advisor **Category**:Medical Affairs**Location**:Bangalore, Karnataka, IN**Department**: Global Medical Affairs.- **The position** - The Associate Global Scientific Advisor (AGSA) is expected to be able to work independently according to Novo Nordisk Standard Operating Procedures and Global Medical Affairs strategy. The Associate...

  • Product Associate

    1 month ago


    Bengaluru, India JPMorgan Chase & Co. Full time

    As part of the IPB Digital Advisor & Client Solutions Product team, the IPB Product Manager , is responsible for ensuring that our Advisor’s have a seamless end-to-end experience across their digital ecosystem. Through partnership with the business, advisors, senior leaders, designers, and technologists, the Product Manager will shape the digital product...

  • Wealth Advisor

    1 month ago


    Bengaluru, India PeakAlpha Investment Services Pvt. Ltd. Full time

    WORK WITH INDIA’S BEST FINANCIAL ADVISORS and learn what it takes to be the best in the business MAKE A REAL DIFFERENCE in transforming people’s lives, because their financial health brings real happiness SLEEP IN PEACE EVERY NIGHT knowing you have worked productively and ethically, safeguarding your clients’ money as your own WORK FLEXIBLE HOURS and...

  • Medical Advisor

    2 days ago


    Bengaluru, India Novo Nordisk AS Full time

    Location – Bangalore Are you an experienced medical professional and passionate about Medical Affairs? Does being part of a growing, yet dynamic environment excite you? Is you adept in implementing the medical affairs strategy in the country? If yes, then you may be the one we are looking for as Medical Advisor for Novo Nordisk India. Apply now! ...


  • Bengaluru, India Novo Nordisk Full time

    **Department**: Global Medical Affairs. **The position** The Associate Global Scientific Advisor (AGSA) is expected to be able to work independently according to Novo Nordisk Standard Operating Procedures and Global Medical Affairs strategy. The Associate GSA strives to be the specialist on the product/project within his/her responsibility. The Associate...

  • Medical Advisor

    4 weeks ago


    Bengaluru, Karnataka, India Novo Nordisk Full time

    Medical Advisor - Cardiovascular & Emerging Therapy Areas **Category**:Medical Affairs**Location**:Bangalore, Karnataka, IN**Location - **Bangalore- **The position** - As a Medical Advisor, you will contribute actively to devise and implement the medical affairs strategy in the country, be a specialist in the therapy area and allotted product/portfolio. You...