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Director, Drug Safety Surveillance – PV Scientist
Ionis Pharmaceuticals, Inc.Provides pharmacovigilance support to assigned molecules within Ionis. Ensures high quality of reports and performs safety signal detection activities.
About the role
Key responsibilities & impact- Provides safety science and pharmacovigilance support to assigned molecules within Ionis portfolio
- Ensuring high quality of aggregate report production
- Development of risk management documents in collaboration with Drug Safety Physicians
- Safety review meeting coordination
- Signal detection activities as well as evaluating emerging safety data from all sources
- Identifying and managing safety signal(s)
- Authoring key sections of periodic safety reports and other PV documents
- Providing safety support for clinical development
Requirements
What you’ll need- Bachelor’s degree in life sciences and 12 years of related experience in pharmacovigilance in a pharmaceutical or biotechnology company
- Advanced degree in healthcare profession strongly preferred (e.g., MD, PharmD, PhD with at least 5 years of related experience
Benefits
Comp & perks- Competitive salary
- Highly competitive benefits
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
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Hard Skills & Tools
pharmacovigilancerisk managementsignal detectionaggregate report productionsafety data evaluationperiodic safety reportssafety signal managementclinical development support
Soft Skills
coordinationcollaboration
Certifications
Bachelor’s degree in life sciencesMDPharmDPhD