Senior Safety Physician

Shionogi; Amsterdam; Sur place; GBP 110 000 - 140 000; Plein temps

Résumé du poste

Shionogi is seeking an experienced (Senior) Safety Physician to join our European Drug Safety team. The role covers pharmacovigilance activities across both development and marketed products, providing medical judgment and regulatory input in a hands‑on, international environment.

You will review ICSRs and listings, contribute to signal management, design EU RMPs and PSURs, and support PASS and real‑world studies while collaborating with colleagues across Europe and beyond.

Qualifications

• Medical degree and registration/licence to practice in the location.
• 5+ years in the pharmaceutical industry with pharmacovigilance focus across development and marketed products.
• Strong knowledge of GVP, GCP and relevant ICH guidance.
• Good knowledge of European and global pharmacovigilance regulations.
• Experience with EU RMPs, PSURs, PASS and regulatory commitments from a PV perspective.
• Clinical trial and GCP experience.
• Experience working in cross‑functional teams.
• Strong organisational, planning, prioritisation and problem‑solving skills.
• Ability to manage complex assignments to demanding timelines.
• Excellent written and verbal communication across countries.

Responsabilités

• Provide PV input into Marketing Authorisation Applications and safety variations.
• Medical review of individual case safety reports (ICSRs) and aggregate listings.
• Contribute to signal management for developmental and marketed products.
• Plan, author and maintain EU RMPs and periodic safety reports (PSURs/PBRERs/DSURs).
• Contribute to PASS and real‑world evidence study design and execution.
• Provide medical safety input into study protocols, ICFs and CSR documents.
• Support safety communications and regulatory procedures across geographies.
• Act as Global Drug Safety Representative for assigned products when required.
• Support inspection readiness for GVP and GCP audits and responses.

Connaissances

Pharmacovigilance

GVP knowledge

Cross-functional teamwork

Medical judgment

Regulatory know‑how

English proficiency

Formation

Medical degree

Medical registration/licence

Description du poste

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.