You will lead and delivery senior expert contributions to proactive pharmacovigilance with rapid identification and analysis of safety signals, benefit-risk evaluations, proactive initiation and efficient implementation of risk minimization measures, and go/no-go decisions at critical development and life-cycle stages for the entire Consumer Health portfolio.
As Safety Product Leader for a dedicated product portfolio, you will integrate complex safety data and deliver high quality documents, such as PBRERs, PSURs, ARs, SBRs, DSURs, pSUSARs, Addendum to Clinical Overviews, Risk Management Plans and updates, Safety Analyses, Expert Statements and other supporting documents for variations and answers to objections. You will further perform medical review and quality control steps for safety outputs generated by Global Product Safety.
- Degree in medicine – a doctorate would be desirable
- Minimum of 8+ years of experience in pharmacovigilance and clinical safety
- Excellent proficiency in signal detection and evaluation and of continuous Benefit Risk Assessment
- Proven exceptional data analysis capabilities
- Comprehensive mastery of global regulatory requirements for drug safety and pharmacovigilance
- Excellent medical judgment in safety decision making
- Leadership experience (e.g. in projects)
- Future-oriented mindset and high degree of flexibility
- English – business fluent
German – nice to have
Standort: Darmstadt & remote
Projektlaufzeit: 31.12.2018 mit Verlängerungsoption
Verfügbarkeit: 80 Tage, 50% remote