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

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

Qualifications

Commensurate with experience

Skills

Not specified

Benefits

Not specified

Pay

TBD

Schedule

TBD

About the role

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

Job Nature

Full-time

No. of Vacancies

1

Job Location

Remote

Job Level

Mid-Senior

Share On

Not specified

How to Apply

Interested candidates can send their resumes to info@acdlimited.com mentioning "Job Title" in the subject line.

Apply Online