Senior Scientist, Safety Analysis Scientist
4 semanas atrás
Senior Scientist, Safety Analysis Scientist
Position located in Lisbon, Portugal.
Job Summary
Johnson & Johnson Innovative Medicine is recruiting for a Senior Scientist, Safety Analysis Scientist. Positioned in Lisbon, Portugal, this role is integral to our commitment to building a world where complex diseases are prevented, treated, and cured. The Senior Scientist will provide scientific expertise and lead the safety assessment of assigned products, collaborating with cross‑functional safety partners to determine safety strategy, complete safety analyses and evaluations, and support regulatory compliance.
Key Responsibilities
- Lead safety evaluations, including strategy discussions, data retrieval, data analysis, report writing, and report revision.
- Ensure high‑quality safety evaluations and reports with limited revisions needed.
- Provide support to Associate Director (AD) SAS and Manager SAS for novel projects.
- Review and provide input on key regulatory or clinical documents as appropriate.
- Demonstrate leadership in the SMT and support the MSO.
- Support SMT activities (e.g., preparing and communicating data, compiling meeting minutes, updating signal tracking information).
- Lead proactive safety data reviews and establish a safety position across Global Medical Safety.
- Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
- Participate in department and/or cross‑functional initiatives.
- Support audits/inspections.
Education & Experience Requirements
- Bachelor’s Degree Required: Healthcare‑related or Biomedical Science (6+ years industry experience or equivalent).
- Advanced Degree Preferred: Healthcare‑related or Biomedical Science (4+ years industry experience or equivalent).
- Medical writing or PV experience required.
- Clinical experience preferred.
Required Skills
- Solid understanding of medical concepts and familiarity with safety activities in drug development and post‑marketing and global safety health authority requirements.
- Ability to understand and analyze complex medical‑scientific data from a broad range of sources.
- Ability to interpret and present complex data to determine benefit‑risk impact.
- Excellent English verbal and written communication skills.
- Ability to effectively interact with team members, including business partners.
- Ability to work in a cross‑functional team environment, leadership skills.
- Ability to plan work to meet timelines and effectively balance multiple priorities.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Ability to influence, negotiate and connect with both internal and external customers.
Preferred Skills
- Clinical Operations
- Coaching
- Critical Thinking
- Data Reporting
- Medicines and Device Development and Regulation
- OSHA Compliance
- Quality Control (QC)
- Researching
- Risk Compliance
- Safety Investigations
- Safety‑Oriented
- Serious Adverse Event Reporting
- Standard Operating Procedure (SOP)
- Technical Writing
- Technologically Savvy
Seniority Level
- Not Applicable
Employment Type
- Full‑time
Job Function
- Research, Analyst, and Information Technology
Industries
- Pharmaceutical Manufacturing
Due to the upcoming Christmas holidays, we are expecting to have business interviews for this role in January.
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