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Advisor / Senior Advisor - GPS Global Medical Review, Cork
Client: Lilly
Location: Cork, Ireland
Job Category: Other
EU work permit required: Yes
Job Reference:
b743e4707b0d
Job Views:
87
Posted:
21.01.2025
Expiry Date:
07.03.2025
Job Description:
We’re looking for people who are determined to make life better for people around the world.
Organisation Overview:
At Eli Lilly Cork, 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 41,000 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’ wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, Age & Culture, LGBTQ+ and GIN-Gender Inclusion Network.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Primary Responsibilities:
Medical support of individual case adverse event reporting process:
1. Provide the medical and clinical expertise necessary to support Safety Management Associate and Call Center staff involved in receiving, preparing, and reporting adverse events.
2. Provide medical technical expertise in evaluation of adverse events, supporting the Safety Management staff in ensuring appropriate follow-up, reviewing assessments, providing review for the medical content of Individual Case Safety Reports (ICSRs) as needed, and making the determination of the company’s assessment of relatedness for applicable ICSRs.
3. Identify or help support evaluation of potential quality issues with Lilly products that may adversely affect patient safety.
4. Assist in supporting customer response activities associated with adverse events.
GPS Medical Leadership:
1. Contribute to the global assessment of safety of Lilly products and molecules in clinical trials by interacting directly with the GPS Medical physicians and scientists and Safety Surveillance Teams (SSTs).
2. Assist SSTs in review of specific individual ICSRs, bringing clusters of ICSRs from clinical trials suggesting a safety signal to the attention of SSTs.
3. Build collaborative working relationships with other physicians and scientists in GPS Medical as well as Development and Brand Teams globally.
4. Participate in process development, quality review, continuous inspection and audit preparedness and inspection/ audit support.
5. Act as the Lilly GPS Medical Review representative for both internal and external customers.
Understanding and support of the QPPV role:
1. Understand the roles and responsibility of the European Union Qualified Person for Pharmacovigilance (QPPV).
2. Ensure support is provided to enable the QPPV to fulfil the QP legal responsibilities.
Other Job Expectations:
1. Meet the R&D Titles Expectations as outlined in the R&D Titles Framework.
2. Maintain medical expertise in areas of interest or specialty.
3. Understand and comply with all compliance policies, laws, regulations, and the Red Book.
4. Adapt to the changing global regulatory environment.
5. Ensure that an appropriate confidentiality agreement has been executed before disclosing confidential company information to outside parties.
Minimum Requirements:
1. Advanced medical related graduate degree, such as: DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) with 1-3 years of experience in related scientific field, e.g., pharmacology, physiology, microbiology or scientifically related field.
2. OR BS degree in a health-related or scientific field with 7-10 years of experience in pharmaceutical industry, directly related clinical trial experience or experience in areas relevant to drug discovery or development.
3. Strong written, spoken, and presentation communication skills.
4. Ability to influence others in order to create a positive working environment.
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.
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