Associate Director, Medical Safety (Scientist)
Jazz Pharmaceuticals
4 days ago
Remote
United States
Medical Affairs
Essential Functions:
- Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program.
- Ensures safety processes and procedures are up to date to meet regulatory requirements and inspection readiness.
- Drives signal management using available methodologies; recommends assessment and prioritization of safety concerns.
- Communicates with interdisciplinary teams regarding ongoing signal evaluation.
- Evaluates safety information to meet internal/external requirements, including identifying need for labeling updates; produces accurate evaluation documents with clear conclusions.
- Coordinates aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections as appropriate.
- Authors or provides guidance for risk management plans (RMPs).
- Provides strategic input into regulatory requests/responses.
- Delivers clinical safety input into clinical development programs.
- Leads medical safety contributions of global regulatory submissions for new products/formulations/indications.
- Participates in and/or leads safety surveillance and joint safety meetings with licensing partners.
- Provides input into Safety Data Exchange Agreements and/or other PV agreements.
- Escalates issues/concerns to senior management timely.
- Mentors and trains junior Medical Safety team members.
Minimum Requirements:
- At least 6 years drug safety experience, including at least 4 years surveillance/risk management.
- Ability to independently search clinical safety and literature databases.
- Expert pharmacovigilance knowledge for aggregate safety reports, RMPs, and signal management.
- Excellent medical writing; ability to lead interdisciplinary teams.
- In-depth medical/drug terminology knowledge and clinical development process.
- Familiarity with MedDRA and safety databases; proficient with Windows; ability to learn new programs/databases.
Education:
- Degree (BS/BA/MSc/PhD) or professional life-science qualification (e.g., nursing/pharmacy) or relevant scientific/technical discipline and experience.
Application instructions:
- If you are a current Jazz employee, apply via the Internal Career site.
- Remote.
- Leads cross-functional safety management teams (SMTs) and drives safety strategy for responsible product/program.
- Ensures safety processes and procedures are up to date to meet regulatory requirements and inspection readiness.
- Drives signal management using available methodologies; recommends assessment and prioritization of safety concerns.
- Communicates with interdisciplinary teams regarding ongoing signal evaluation.
- Evaluates safety information to meet internal/external requirements, including identifying need for labeling updates; produces accurate evaluation documents with clear conclusions.
- Coordinates aggregate safety reports (PBRERs, DSURs, PADERs) and authors relevant sections as appropriate.
- Authors or provides guidance for risk management plans (RMPs).
- Provides strategic input into regulatory requests/responses.
- Delivers clinical safety input into clinical development programs.
- Leads medical safety contributions of global regulatory submissions for new products/formulations/indications.
- Participates in and/or leads safety surveillance and joint safety meetings with licensing partners.
- Provides input into Safety Data Exchange Agreements and/or other PV agreements.
- Escalates issues/concerns to senior management timely.
- Mentors and trains junior Medical Safety team members.
Minimum Requirements:
- At least 6 years drug safety experience, including at least 4 years surveillance/risk management.
- Ability to independently search clinical safety and literature databases.
- Expert pharmacovigilance knowledge for aggregate safety reports, RMPs, and signal management.
- Excellent medical writing; ability to lead interdisciplinary teams.
- In-depth medical/drug terminology knowledge and clinical development process.
- Familiarity with MedDRA and safety databases; proficient with Windows; ability to learn new programs/databases.
Education:
- Degree (BS/BA/MSc/PhD) or professional life-science qualification (e.g., nursing/pharmacy) or relevant scientific/technical discipline and experience.
Application instructions:
- If you are a current Jazz employee, apply via the Internal Career site.
- Remote.