Medical Safety Officer, Immunology at J&J; Family of Companies.
About the role At Johnson & Johnson, we place a strong emphasis on health as an essential element of life.
Our dedication to advancing healthcare innovation enables us to envision a future where complex diseases are not only treated but also prevented and effectively managed.
We are committed to developing advanced, less invasive treatment options and personalized healthcare solutions that significantly enhance health outcomes for patients.
Key facts
Location: Horsham, Montgomery County Engagement: Full time Compensation: $150,399 Team: Immunology
What you'll do
Manage the comprehensive safety evaluation of immunology products throughout their entire lifecycle, from development to post-market surveillance.
Collaborate with various cross-functional teams, including clinical development, regulatory affairs, and quality assurance, to ensure adherence to regulatory requirements and internal policies.
Conduct thorough risk assessments and safety signal detection for immunology products, ensuring timely identification and mitigation of potential safety issues.
Prepare and review safety-related documents, including clinical study reports, safety updates, and regulatory submissions, to ensure accuracy and compliance.
Serve as a key point of contact for safety-related inquiries from regulatory authorities, healthcare professionals, and internal stakeholders.
Lead safety meetings and discussions, providing expert insights and recommendations based on safety data analysis.
Develop and implement safety monitoring plans and strategies to enhance product safety and efficacy.
Stay updated on industry trends, regulatory changes, and emerging safety issues in the field of immunology to inform safety practices and policies.
Mentor and train junior staff members on safety evaluation processes and regulatory compliance.




Contribute to the continuous improvement of safety assessment methodologies and tools within the organization.
Participate in audits and inspections related to safety practices, ensuring readiness and compliance with regulatory standards.
Collaborate with external partners and stakeholders to share safety information and best practices.
Requirements
A minimum of 5 years of experience in medical safety, pharmacovigilance, or a related field within the pharmaceutical or biotechnology industry.
A relevant degree in a scientific discipline, such as medicine, pharmacy, or life sciences, is required.
In-depth understanding of regulatory requirements and guidelines pertaining to drug safety and pharmacovigilance.
Proven experience in risk management and safety signal detection methodologies.
Strong analytical skills with the ability to interpret complex safety data and generate actionable insights.
Excellent written and verbal communication skills, with the ability to convey complex information clearly to diverse audiences.
Demonstrated ability to work collaboratively in a team-oriented environment and manage multiple projects simultaneously.
Nice to have
Advanced degree (Master's or PhD) in a relevant scientific field.
Experience with safety databases and electronic reporting systems.
Familiarity with clinical trial processes and regulatory submissions.
Previous experience in the immunology therapeutic area is a plus.
Knowledge of global pharmacovigilance regulations and practices.
Certification in pharmacovigilance or drug safety is advantageous.
Skills & tools
Proficient in data analysis techniques and tools, with the focus on safety data interpretation.
Familiarity with safety databases, such as Argus or Oracle, and reporting tools.
Strong project management skills, with the ability to prioritize tasks effectively.
Excellent interpersonal skills, enabling effective collaboration with diverse teams and stakeholders.
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📌 Medical Safety Officer, Immunology (Horsham)
🏢 J&J Family Of Companies
📍 Horsham