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Associate Safety Director / Portfolio Safety ScientistManpower Basel • Basel, Basel-Stadt, Switzerland
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Associate Safety Director / Portfolio Safety Scientist

Manpower Basel
  • CH
    Basel, Basel-Stadt, Switzerland
  • CH
    Basel, Basel-Stadt, Switzerland
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À propos

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Wir suchen eine:n Senior Associate Scientist / Analytical Development (m/w/d) – Basel
Associate Safety Director / Portfolio Safety Scientist
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 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 or another relevant healthcare or life sciences qualification.
Experience as subject expert, business process owner or safety committee member.
Experience working with vendors in a safety science or pharmacovigilance environment.
Strong process improvement mindset and experience in cross-functional global teams. jidea4fdb9ws jit0625ws jiy26ws
  • Basel, Basel-Stadt, Switzerland

Compétences linguistiques

  • English
Avis aux utilisateurs

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