Boehringer Ingelheim is hiring a

Principal / Senior Global Patient Safety Writer

Ingelheim am Rhein, Germany

The Position

Join our team as a Principal / Senior Global Patient Safety Writer and play a pivotal role in authoring key regulatory pharmacovigilance documents. You will be working on important projects and products, collaborating closely with our dedicated project teams to ensure the quality and timeliness of our pharmacovigilance documents for submission to global health authorities.

As a key member of our team, you will write pharmacovigilance documents for our core and development products and tackle projects with a high level of complexity. Your expertise will be invaluable in guiding our team and mentoring other PSPV writing team members, as well as external staff.

This role offers an exciting opportunity to contribute to our mission while growing your career in a dynamic and supportive environment. We are looking for someone who is ready to take on challenges and make a difference in the world of patient safety.

This position can be filled either as Principal Global Patient Safety Writer or Senior Global Patient Safety Writer.

Tasks & responsibilities

In your role as Principal / Senior Global Patient Safety Writer, you will author crucial regulatory PV documents like DSURs, PBRERs/PSURs, and RMPs for our projects and products. In close collaboration with our dedicated project teams, you will ensure the timeliness and quality of our PV documents and provide mentorship to other PSPV writing team members and external staff.
As a key player, you will be the liaison between various functions such as PSPV, Regulatory Affairs, Medical Affairs, and Epidemiology. Your role will involve facilitating issue resolution by coordinating and leading meetings focused on PV document content, helping our cross-functional teams reach consensus on data interpretation and presentation.
Your expertise will be crucial in preparing, maintaining, and providing input to our Standard Operating Procedures, guidelines, and working instructions. You ensure that our operations run smoothly and efficiently.
You will also have the opportunity to shape the future of our team by preparing specific document-related trainings for the PSPV Writing Group and other functions. As a mentor, you will guide new team members, helping them to grow and succeed in their roles.
Finally, you will be in charge of detailed planning of PV documents, including timelines, coordination of authors and reviews, and document content. You ensure that our products are always timely and of high quality, acting as the liaison between possible contractors and the project team.

Additional tasks for Principal Safety Writer:

You take an active role in the development of global submission strategies for RMPs, PBRERs and DSURs. Your strategic expertise will be decisive in liaising with global, regional, and local functions, ensuring smooth RMP management and global submission planning.
As a problem-solver, you will facilitate resolution for global Therapeutic Area Teams, coordinating and leading activities focused on the content and timelines of PV documents. You will help cross-functional teams reach consensus on data interpretation, presentation, and overall strategy, making accountable decisions to ensure compliance with regulatory timelines.
You will also have the opportunity to develop and implement innovation strategies, driving continuous improvement of processes related to the creation of PV documents. 
As a mentor, you will provide functional expertise and guidance to global TA Teams, PSPV writing team members, and external staff.
Lastly, you will lead the creation of PV documents for core products and/or products with a high level of complexity.

Requirements

We are seeking a candidate with a Diploma or Masters degree in Life Sciences
Bring along your several years of experience in medical writing and ideally in pharmacovigilance within the pharmaceutical industry
We value your proven track record in authoring clinical and pharmacovigilance specific regulatory documents
Your exceptional problem-solving skills will be put to good use, enabling you to navigate through complex situations
Your ability to prioritize and organize work as well as to meet deadlines within an interdisciplinary team setting will be key to your success in this role
High proficiency in MS Office and document-management applications is a must
We appreciate excellent English language communication skills, both written and oral

Additional requirements for Principal Safety Writer:

Your thorough understanding of global regulations and guidelines, combined with proven skills in developing global submission strategies, will be invaluable in navigating the global landscape
Proven regulatory expertise is a must

Ready to contact us? 

If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or via mail: hr.de@boehringer-ingelheim.com

Recruitment process:

Step 1: Online application - The job posting is presumably online until February 6th, 2026. We reserve the right to take the posting offline beforehand. Applications up to January 23rd, 2026 are guaranteed to be considered.

Step 2: Virtual meeting in the period from mid of January

Step 3: On-site interviews beginning mid of February

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