Associate Director/ Senior Manager / Manager – Global Patient Safety...

Alpha Clinical Development; New York (NY); On-site; USD 120,000 - 150,000; Full time

Job summary

A leading clinical research organization is seeking an experienced Global Patient Safety Scientist to manage safety strategies for clinical development products. This role requires a Master's, PhD, or PharmD, alongside at least 5 years of relevant experience in the pharmaceutical industry. The candidate will perform signal detection and analysis, prepare safety documentation, and engage in cross-functional team meetings. Competitive compensation and full-time position in New York, US.

Qualifications

• 5+ years of experience in risk management or relevant clinical experience.
• Previous safety experience in the pharmaceutical industry.
• Ability to communicate safety findings effectively.

Responsibilities

• Perform safety data aggregation and analysis.
• Manage preparation of safety documents.
• Participate in risk management activities.
• Deliver presentations at SMT meetings.

Skills

Signal detection activities

Risk management

Safety data analysis

FDA guidelines

Communication skills

Education

Master's, PhD, or PharmD

Job description

# Associate Director/ Senior Manager / Manager – Global Patient Safety Scientist##### Overview| || --- || **Position Summary** **Summary** Global patient safety scientist (GPS Scientist) will play a key scientific role in safety strategies for assigned products in clinical development and post marketing. This will include safety data aggregation, review and analysis to support appropriate safety interpretation and benefit-risk assessment. **Responsibilities** • Perform signal detection activities for assigned products in line with approved safety surveillance plan • Perform signal evaluation for any identified signals and author the safety evaluation report. • Manage preparation and review of safety documents including DSUR, PSUR, RMP, response to health authority or other stakeholder queries etc • Prepare and deliver presentations at SMT meetings; participate in clinical study team meetings as appropriate for assigned products. • Participate in other risk management activities as appropriate for assigned compounds. • May represent GPS for assigned compounds on cross-functional teams, including Safety Oversight Committee, Independent Data Monitoring Committees and other teams with members external • Actively participate in process improvement initiatives e.g. the development and maintenance of relevant SOPs, WIs and supporting documents. **Requirements** • Master's, PhD, or PharmD • Previous safety or relevant clinical experience in the pharmaceutical industy required, typically with at least 5 years of risk management or relevant clinical experience in pharmaceutical/ biotech industry or health authority. • Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments. • Ability to utilize GPS safety system database for purposes of medical case review and simple queries. • Ability to effectively communicate (verbal and written) safety findings. - |##### No. of Vacancies1##### Job NatureFull-time##### Experience Requirements5##### Job LocationNew York, US##### Job LevelSr. Position##### Share On### How to Apply Interested candidates can send their resumes to [e-mail] mentioning "Job Title" in the subject line.