Senior Manager Medical Device Safety, Pharmacovigilance

Us tech Solutions; Whippany (NJ); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Us tech Solutions is seeking a Senior Manager Medical Device Safety in Whippany, NJ. This role involves ensuring effective Vigilance and Post-Marketing Surveillance (PMS) for medical devices, with a focus on regulatory compliance and safety data analysis. The ideal candidate has a Bachelor's Degree in a relevant field and significant experience in the medical devices sector.

The position requires strong analytical skills, a solid understanding of medical device regulations, and the capability to work independently and in teams. The role offers a diverse work environment that includes both office and virtual settings.

Qualifications

• 4 years of professional experience in medical devices or a related sector.
• Heavy statistical analysis experience.
• Ability to develop and administer management information systems.

Responsibilities

• Provide content input to project teams for safety data analyses.
• Assist in PMS program activities, including documentation and planning.
• Review large data sets and prepare reports for Health Authorities.

Skills

Strong scientific statistical methods

Medical device trending/signal detection

Analytical and technical skills

Communication skills

Education

Bachelor's Degree in Engineering, Mathematics, or Life Sciences

Job description

Senior Manager Medical Device Safety, Pharmacovigilance

Duration: 12 Months

Location: Whippany, NJ 07981

Job Description: The Senior Manager Medical Device Safety (MDS) carries out global Pharmacovigilance (PV) business processes and analyzes safety data sets related to complaint handling, regulatory reporting, and clinical development for company medical devices and combination products. The role provides safety oversight and contributions to design control, clinical evaluations, vigilance reporting, trending and post‑marketing surveillance for company medical devices worldwide.

Position Summary

The incumbent provides counsel as a PV medical device subject matter expert to ensure effective vigilance, post‑marketing surveillance (PMS), and trending systems that conform to global requirements. They work cross‑functionally to implement process standards consistent with device industry best practices.

Key Responsibilities

• Provide content input to project teams for designing, planning, and conducting safety data analyses.
• Assist in PMS program activities, including documentation, planning, and report management.
• Develop and execute PMS trending methodologies, write contributions, and prepare trend reports.
• Monitor, analyze, and apply trending methodologies to vigilance data submitted to health authorities (e.g., MDRs).
• Review large data sets and prepare reports for submission to Health Authorities under strict timelines, resolving queries regarding product safety.

Requirements

• Education: Bachelor's Degree in Engineering, Mathematics, or Life Sciences with 4 years of professional experience in medical devices or a related sector.
• Skills & Competencies:
  • Strong scientific statistical methods for evaluating complaint trends and establishing thresholds for routine trend reviews.
  • Background in medical device trending/signal detection and heavy statistical analysis experience.
  • Ability to develop and administer management information systems for tracking and trending.
  • Strong analytical and technical skills for data collection, analysis, and report generation.
  • Strong communication skills and ability to work independently and cross‑functionally with Quality, Regulatory, Marketing, and other functions.
  • Working understanding of medical device regulations and industry standards globally (21 CFR 820, 803, ISO 13485, EU MDR 2017/745).

Preferences

• Comfortable working in both office and virtual settings independently.

All your information will be kept confidential according to EEO guidelines.