Senior Safety Physician

Why join Shionogi?

At Shionogi, safety is at the heart of what we do.
We are looking for an experienced (Senior) Safety Physician to join our European Drug Safety team and play an important role in our pharmacovigilance activities across both clinical development and marketed products.
This is a hands-on position with broad exposure across the safety lifecycle. You will work with colleagues across Europe and globally, combining medical expertise with strong pharmacovigilance knowledge to support effective benefit-risk evaluation, regulatory activities, signal management and the continued development of our safety capabilities.
For someone who enjoys combining scientific and medical judgement with practical delivery in an international pharmaceutical environment, this is an opportunity to make a meaningful contribution.

As a (Senior) Safety Physician, you will contribute across a broad range of pharmacovigilance activities, including:

• Provide pharmacovigilance input into Marketing Authorisation Applications, responses to health authority requests and safety variations.
• Perform medical review of individual case safety reports (ICSRs) and aggregate line listings across clinical trials and post-marketing activities.
• Contribute to signal management activities for both developmental and marketed products, including the identification and evaluation of safety signals from available sources.
• Plan, author and maintain EU Risk Management Plans (RMPs) and periodic aggregate safety reports, including PSURs/PBRERs and DSURs.
• Contribute to the design, implementation and execution of Post-Authorisation Safety Studies (PASS) and other real-world evidence projects.
• Provide medical and scientific safety input into study protocols, informed consent forms and clinical study reports.
• Contribute to benefit-risk assessments, regulatory procedures and safety communications.
• Act as Global Drug Safety Representative for assigned products where required, coordinating periodic safety review and signal management activities.
• Act as local drug safety representative and/or Safety Physician for assigned clinical trials.
• Support safety wording, including safety sections of the SmPC and CCSI.
• Support inspection readiness for GVP and GCP audits and inspections, including the timely preparation of responses to findings.
• Prepare procedures and training materials and deliver safety training where appropriate.
• Provide medical support to the QPPV and deputy/back-up functions as required.
• Represent the Shionogi Europe Safety function in relevant local and global projects and discussions.

Essential

• A medical degree.
• Appropriate medical registration/licence where required for the role and location.
• At least five years’ pharmaceutical industry experience, predominantly within pharmacovigilance and covering both development and marketed products.
• Strong medical knowledge and understanding of GVP, GCP and relevant ICH guidance.
• Good knowledge of European and global pharmacovigilance regulations and pharmaceutical research and development.
• Practical experience with EU RMPs, PSURs, PASS, regulatory commitments, health authority responses and MAA procedures from a pharmacovigilance perspective.
• Clinical trial and GCP experience.
• Experience working within cross-functional teams.
• Strong organisational, planning, prioritisation and problem-solving skills.
• The ability to manage complex assignments and work effectively to demanding timelines.
• Confidence working both independently and collaboratively.
• Strong written and verbal communication skills, including working with stakeholders across different countries and functions.
• Fluent written and spoken English.
• An understanding of epidemiology, statistics and risk-management principles.

Desirable

• Postgraduate specialisation within a relevant therapeutic area.
• Previous clinical practice experience.
• Experience working with a Japanese organisation.

Knowledge of another language, particularly German, Spanish, Italian, French, Dutch or Japanese.

How you work
You will be joining an international environment, so we are looking for someone who is:

• Approachable, flexible and self-motivated.
• Resilient, resourceful and comfortable navigating complex situations.
• Open to change, new ideas and continuous improvement.
• Detail-oriented while still able to see the broader safety and business context.
• Comfortable taking a practical, hands-on approach to delivery.

Location
This position can be based in Amsterdam, London or Berlin.