Manager, Safety Analysis Scientist

About the role

Manager, Safety Analysis Scientist position available in Horsham, PA; Titusville, NJ; or Raritan, NJ. The role provides scientific expertise for safety assessment of assigned products, partnering with the Medical Safety Officer to support regulatory compliance and safety‑related decision‑making for marketed and in‑development products.

Responsibilities

• Leading safety evaluations, including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other team members as necessary, data retrieval, data analysis, report writing, and report revision.
• Ensuring high quality safety evaluations and reports with minimal‑to‑moderate comments from team members and minimal‑to‑moderate revisions required.
• Providing support to AD SASs for novel projects without defined processes.
• Providing input and review to key regulatory or clinical documents as appropriate.
• Demonstrating leadership in the SMT and support the MSO.
• Supporting SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
• Leading proactive safety data reviews.

Requirements

• Bachelor’s Degree required: Healthcare‑related or Biomedical Science (9+ years industry experience or equivalent).
• Advanced Degree preferred: Healthcare‑related or Biomedical Science (6+ years industry experience or equivalent).
• Medical writing or PV experience required.
• Clinical experience preferred.
• Working knowledge of medical concepts and familiarity with safety activities in drug development and post‑marketing and global safety health authority requirements required.
• Ability to understand and analyze complex medical‑scientific data from a broad range of sources required.
• Ability to interpret and present complex data to determine benefit‑risk impact required.
• Excellent English verbal and written communication skills required.
• Ability to effectively interact with team members, including business partners required.
• Ability to work in a cross‑functional team environment, proven leadership skills required.
• Ability to plan work to meet timelines and effectively balance multiple priorities required.
• Proficiency in Microsoft applications (e.g., Word, Excel, PowerPoint) required.
• Ability to influence, negotiate and connect with both internal and external customers required.

Skills

• Business Alignment
• Clinical Operations
• Coaching
• Compliance Management
• Compliance Risk
• Critical Thinking
• Data Reporting
• Medicines and Device