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 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.
Organisation Overview:
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 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, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself
Responsibilities:
The CRP in GPS Medical has responsibilities associated with the development, management, execution, and oversight of all aspects of the safety program for one (or more) asset(s) throughout the product(s') life cycle. This individual plays a major role in coordinating technical functions within GPS to facilitate these responsibilities. The individual is accountable for collaborative contributions and partnership with the integrated development or product team to deliver on these safety commitments while demonstrating GPS expertise and leadership.
* Provide safety oversight on key GPS Medical activities
o Provide GPS Medical leadership and ensure proactive pharmacovigilance for assigned product(s)
o Demonstrate advanced knowledge of safety concepts, per ICH, US and international regulation/guidelines and GxP
o Synthesize complex data into actionable insights and translate technical issues into strategic discussions
* Act as Lilly GPS Medical representative for both internal and external stakeholder interactions
o Build strong relationships with key stakeholders, representing and championing the role of safety in the organization
o Represent GPS Medical in inspections and audit activities
* Foster and support a collaborative working environment focused on inclusion, innovation, acceleration, and delivery
* Understand and support the Qualified Person for Pharmacovigilance role to fulfill all legal responsibilities
* Provide training, coaching and mentor
o Experience and knowledge sharing to further advance the goals of the GPS group and wider enterprise
o Maintain compliance with corporate policies and relevant training curriculum
Basic Requirements:
* Medical Doctor or Doctor of Osteopathy. Must be board eligible or certified in appropriate specialty/subspecialty or have completed the comparable level of post-medical school clinical training relevant to the country of hiring
* US trained physicians must have achieved board eligibility or certification.
* Non-US trained physicians must have completed education and training at a medical school that meets the minimum requirements substantially equivalent to the requirements of medical schools accredited by the Liaison Committee on Medical Education (LCME). For the recognized list of foreign medical schools and the disapproved list, see PLA: Physicians Licensing Information and Medical Education | MBC
* Knowledge of drug development process
* Fluent in English with highly effective written and verbal communication skills
* Strong clinical/diagnostic skills
* Excellent interpersonal, organizational and negotiation skills
* Ability to work on multiple projects and function effectively in a fast-paced matrixed environment
* Ability to prioritize tasks and shift priorities rapidly to meet tight deadlines
* Ability to influence others (both cross-functionally and within the function) in order to create a positive working environment
* Excellent teamwork skills
* Willing to engage in domestic and international travel to the degree appropriate to support the business of the team
* Knowledge of global pharmacovigilance guidelines, guidances, and regulations (EMA, FDA, etc.) relevant to the activities and responsibilities described above
* Minimum 3+ years' experience in the pharmaceutical industry or clinical care setting.
Additional Skills/Preferences
* Clinical development or pharmacovigilance experience preferred
* Prior experience in clinical trials preferred; academic and/or industry.
* Experience in oncology, hematology or gynecology is a plus.
* Strategic thinking
* Demonstrated success in implementing projects and/or innovating
* Receptive, engaging, and impactful contributor
Additional Information:
* CRP must reside and work in Ireland
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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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