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Principal Safety Scientist

10+ years
Not Disclosed
10 June 4, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Principal Safety Scientist

Location: India
Job ID: 2025-119349
Company: ICON Strategic Solutions (Other Office Based)


About the Role

As a Safety Program Manager, you will lead high-profile safety surveillance programs, ensuring strategic alignment and innovation, and delivering exceptional safety outcomes. This role requires independent program management and extensive collaboration with multiple stakeholders.

Key Responsibilities:

  • Lead and manage assigned safety surveillance programs or work-verticals with minimal supervision

  • Drive safety surveillance activities such as signal management, safety communications, and benefit-risk strategy documentation

  • Manage multiple committees and teams including HAC, SST, SMT, BRAT, SMC, and DMC

  • Contribute to risk management plans (RMPs) and risk minimization measures (aRMMs)

  • Identify risks proactively and develop mitigation strategies, escalating issues promptly

  • Partner with cross-functional teams to ensure accurate safety data collection and reporting

  • Represent Safety Surveillance in audits and inspections

  • Author and review quality documents (SOPs, MIs, RTs)

  • Assess regulatory impacts and update safety processes accordingly

  • Oversee vendor deliverables and maintain project collaboration

  • Support core trial teams within Global Program Team frameworks (Alliance, HOM, OSM, etc.)


Qualifications and Experience:

  • PhD or advanced degree in life sciences, biotechnology, pharmacy, or related field preferred

  • Bachelor’s degree with significant relevant experience is acceptable

  • Minimum 10 years’ experience in pharmacovigilance, clinical safety, or safety surveillance

  • Proven skills in safety program management, regulatory compliance, and cross-functional collaboration

  • Experience mentoring teams and managing complex developmental projects

  • Strong process improvement and project management skills