Principal / Senior Global Patient Safety Writer

Stellenbeschreibung:

Principal / Senior Global Patient Safety Writer

Join Boehringer Ingelheim as a Principal / Senior Global Patient Safety Writer and play a pivotal role in authoring key regulatory pharmacovigilance documents.

Responsibilities

Write crucial regulatory PV documents such as DSURs, PBRERs/PSURs, and RMPs for core and development products.
Collaborate with project teams to ensure timely and high‑quality PV documents for submission to global health authorities.
Act as liaison between PSPV, Regulatory Affairs, Medical Affairs, and Epidemiology to facilitate issue resolution and coordinate PV content meetings.
Prepare, maintain, and provide input to SOPs, guidelines, and working instructions, ensuring smooth operations.
Mentor and guide PSPV writing team members, external staff, and new hires.
Plan PV document timelines, coordinate authors and reviews, and manage contractor relationships.
Develop global submission strategies for RMPs, PBRERs, and DSURs, leading cross‑functional collaboration.
Drive continuous improvement of PV document creation processes and implement innovation strategies.

Qualifications

Diploma or Master’s degree in Life Sciences.
Several years of experience in medical writing, ideally in pharmacovigilance within the pharmaceutical industry.
Proven track record in authoring clinical and pharmacovigilance regulatory documents.
Exceptional problem‑solving skills and ability to navigate complex situations.
Strong prioritization and organization skills, with a focus on meeting deadlines in interdisciplinary teams.
High proficiency in MS Office and document‑management applications.
Excellent English language communication skills, both written and oral.
For Principal role: deep understanding of global regulations, proven regulatory expertise, and experience developing global submission strategies.