Patient Safety and Regulatory Associate/Sr. Associate

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.

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.

The Opportunity:

We have an exciting opportunity to join our Nordic Patient Safety and Regulatory Affairs team. The role includes responsibilities for a broad range of pharmacovigilance and regulatory activities across the Nordic countries. The role will be tailored based on the selected candidate’s prior experience and interests.

We are looking for you if you thrive on teamwork, responsibility and driving results, are proactive and take initiative, have a high-quality mind-set and a genuine will to contribute within patient safety and regulatory.

You will be a part of an engaged and diverse Nordic team with colleagues across the Nordic countries. The team focus is on inclusion, innovation and delivering results. You will work in an exciting international and cross-functional environment, closely collaborating both face-to-face and virtually with colleagues across the global organization and Nordic affiliates to ensure regulatory compliance and safety of our products to the patients.

The role can be based in either Sweden or Finland. We offer a flexible hybrid working environment with the opportunity to work 3 days a week from the office and 2 days from home. The position reports to Sr. Patient Safety Manager, Nordics.

Start time will be as agreed with the selected candidate, and applications will be reviewed on a rolling basis until the position is filled.

This is your opportunity to make a difference in an innovative global company in a position characterized by strong teamwork, impact and high integrity.

Key Responsibilities:

Patient Safety:

· Adverse event (AE) management: Point of contact for collection of AE reports, timely case entry into the safety database, case follow-up activities, reconciliation of case reports with various stakeholders, quality check and archiving of pharmacovigilance documents.

· Literature screening of local medical journals.

· Ensure that local Third Parties’ Pharmacovigilance agreements are in place, up-to-date and followed as required.

· Provide training for affiliate employees and/or business partners, support affiliate personnel in patient safety requirements and processes.

· Support in maintaining the Pharmacovigilance System Master File and associated local documents.

Regulatory Affairs:

· Support Global Regulatory Affairs applications to obtain and maintain marketing authorizations in the EEA via the Centralized and Mutual Recognition Procedures.

· Ensure that national Product Information complies with local regulatory requirements and global labelling procedures, and that updated Product Information is translated, submitted, approved, and implemented within the designated timelines.

· Create, update, and approve printed packaging materials in collaboration with your regulatory colleagues in the Nordic countries for shared Nordics packs.

· Communicate relevant regulatory information to internal stakeholders.

General responsibilities:

· Ensure effective communication and collaboration between affiliate cross-functional teams to ensure regulatory compliance, good awareness of pharmacovigilance requirements and relevant product information, product supply and successful product launches.

· Represent the team and function in the Nordic and local Brand Teams.

· Ensure appropriate monitoring, interpretation and implementation of relevant national legislation and regulations.

· Maintain, review and update local Standard Operating Procedures.

· Strive for inspection and audit-readiness and participate in aligned affiliate inspections, audits and assessments.

· Act as the primary interface with the local regulatory agency.

· Perform activities related to Risk Minimization Plans.

· Attend appropriate external symposia, conferences and trade organization networks to develop and sustain an appropriate level of professional expertise.

· Keep data in relevant tracking systems up-to-date and accurate.

Required Qualifications

· Master’s degree in pharmaceutical or other relevant science or healthcare related field, or demonstrated equivalent experience in working within pharmacovigilance/regulatory affairs.

Prior working experience in pharmacovigilance or regulatory affairs will be considered an advantage.

· Fluency in Swedish (written and spoken), knowledge of Finnish will be considered an advantage, or fluency in Finnish (written and spoken) and professional proficiency in Swedish, both including professional knowledge of medical terminology.

· Professional knowledge of English, including medical terminology.

About you and your skills:

· You enjoy working in a team and have strong collaboration skills.

· You appreciate diversity and actively contribute to a working environment of trust and mutual respect.

· You work effectively in a virtual setting with colleagues in other countries.

· You work independently, are self-driven and proactive.

· You prioritize and allocate time efficiently to meet deadlines.

· You are well-organized and structured with attention to detail.

· You have good relevant IT skills and a positive and curious approach to new technologies.

Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines.

For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.

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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 (https://careers.lilly.com/us/en/workplace-accommodation) 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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