Global Drug Safety Scientist
Global Drug Safety Scientist
Sobi
Stockholm, Sweden
Global Safety Science are now recruiting a Global Safety Scientist who will be responsible for executing safety surveillance activities for marketed products and products in development. You will provide scientific and technical input to safety surveillance and risk management activities. Subject Matter Expert for safety processes, contributing to the development and maintenance of safety related processes and outputs to support the business needs is part of this role.
Key Responsibilities:
- Be the responsible Global Safety Scientist for assigned products.
- Maintain knowledge of diseases for assigned programs
- Lead signal detection activities, involving identification, evaluation, analysis and interpretation of safety data
- Co-ordinate multidisciplinary Benefit Risk Team (BRT) meetings whose responsibilities include signal detection and validation and making recommendations regarding risk management, communication plan and labeling
- Project Manage the delivery of key safety documents, contributing to high quality and accurate documentation relevant to drug safety outputs
- Leads and/or contributes to risk-benefit evaluations and preparation of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements
- Lead author and/or contributor to the preparation of pre- and post- marketing aggregate safety reports including Periodic Safety Update Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs), Development Safety Update Reports (DSURs and ensure consistent communication of safety topics across various regulatory safety documents for assigned products
- Leads and/ or contributes to the creation and maintenance of Reference Safety Information (RSI) including Investigator Brochures (IB), and Company Core Data Sheet (CCDS)
- Contribute to high quality and timely responses to safety queries
- Provide safety expertise for Clinical Development program(s) and represent safety at strategic development forums
- Participate in inspection readiness activities, internal audits and external inspections
- Maintain knowledge of new PV/safety regulations and guidance from regulatory authorities
- Collaborate with PV Operations, and liaise with PV vendor for assigned products
- Develop or contribute to development of department processes including policies, SOPs and Work Instructions, and other relevant safety documentation
- Contribute to the preparation and review of safety-related section(s) for clinical, regulatory, and scientific documents including, clinical study reports/synopses, integrated summaries of safety, New Drug or Biologic
- License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses.
Qualifications:
- Degree in Life Science or Health Care, Ph.D. degree is preferred
- Experience in the pharmaceutical industry working in pharmacovigilance
- Knowledge of pharmacovigilance related regulatory requirements
- Strong skills in scientific writing
- Good understanding of safety reporting and pharmacovigilance compliance
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