Beschreibung

Background

For the Portfolio Clinical Safety team in Basel, we are looking for an experienced Associate Safety Director / Portfolio Safety Scientist to support safety science and pharmacovigilance activities across the development and marketed portfolio.

In this role, you will contribute to early and late-stage development programmes as part of the safety team and provide scientific input into study management, signal evaluation, benefit-risk assessments, regulatory submissions and risk management activities. The position requires a strong understanding of drug safety, clinical development and regulated GxP processes.

You will work with a high level of independence, manage safety-related responsibilities across assigned products or therapy areas and collaborate closely with global internal and external stakeholders.

General Information

Start date:

Latest possible start date:

Duration: 12 months

Extension: Rather unlikely, but the situation may change

Workload: 100%

Location: Basel

Home Office: Full office presence preferred during the first three months for training, afterwards hybrid model

Travel: No

Working hours: Standard

Team size: 2 to 5 Safety Scientists

Department: PDS/CSC/PCS - Portfolio Clinical Safety Basel

Tasks and Responsibilities

• Develop and maintain an expert understanding of the safety profile of assigned products or therapy areas.
• Understand the relevant strategic context, including disease area, competitor safety profiles and mechanism of action.
• Manage individual and aggregate safety reporting activities, including ICSR medical review, DSURs and PBRERs.
• Support signal detection, signal evaluation and signal management activities.
• Review safety assessments, drug safety reports and safety-related responses to regulatory authority requests.
• Contribute to the development and execution of product safety strategies.
• Take ownership of risk management deliverables, including CCDS, Reference Safety Information, labelling updates, Investigator’s Brochure content, risk communications and Risk Management Plans.
• Review clinical protocols, clinical study reports, informed consent forms, Investigator’s Brochures and other study-related documents.
• Ensure study documents are aligned with the overall safety strategy and appropriate risk communication.
• Prepare and contribute to safety sections of regulatory submissions, including INDs, NDAs, MAAs, variations and renewals.
• Participate in Drug Monitoring Committees, internal monitoring committees and other governance forums where safety input is required.
• Support the presentation of important safety topics to Drug Safety Committees, Development Review Committees and other internal or external review bodies.
• Act independently as the safety representative within study teams and clinical safety-related activities.
• Take responsibility for specialised PCS roles, such as subject matter expert, business process owner or safety committee member.
• Support non-molecule projects, due diligence evaluations and other safety-related initiatives when required.
• Coordinate and collaborate with vendors supporting Safety Science activities.
• Work effectively with global and remote stakeholders in a cross-functional environment.
• Apply complex data analysis and statistical methods to evaluate, interpret and present safety data clearly.
• Contribute to process improvements within Safety Science and related regulated processes.

Required Profile

• Qualified healthcare professional or Life Sciences graduate.
• At least 4 years of experience in drug development within the pharmaceutical industry or a closely related environment.
• Minimum 3 years of experience in drug safety, pharmacovigilance or a closely related safety function.
• Experience at Associate Safety Director level is required.
• Strong knowledge of safety science, pharmacovigilance, GxP requirements and the end-to-end clinical trial lifecycle.
• Proven experience with signal detection, risk management, aggregate reporting and safety documentation.
• Ability to work independently with minimal supervision and strong self-leadership.
• Strong analytical skills, including the ability to extract, analyse and interpret data from safety databases.
• Good MS Office skills, especially Excel, Word and PowerPoint.
• Excellent written and verbal communication skills.
• Strong presentation skills with the ability to summarise complex safety topics, key risks and decision points clearly.
• Fluent English, both written and spoken.

Nice to Have

• Postgraduate qualification such as PhD, MSc, PharmD j4id10257644a j4it0625a j4iy26a