Vaccines Pharmacovigilance Scientist (TKPHJP00001394) (m/f)

REFERENZNUMMER:

374213/11

IHRE AUFGABEN:

-PV support for developmental programs, including both early and late stage development as required
-Supports Vaccines Safety lead for assigned products, e.g. by performing the following activities
-Compilation, analysis and Review of safety data and safety signal management for designated compound(s)
-Prepares/reviews PV section for clinical study protocols, SAPs, clinical study reports, and other documents developed for submission to regulatory authorities
-Prepares/reviews Aggregate Reports: Co-authors Aggregate Reports (PSURs, DSURs) and contributes to the preparation of Ad Hoc Safety Reports (e.g., Health Hazard Evaluations)
-Reviews safety data and participates in dose escalation/continuation of vaccination decisions
-Contributes to Safety Monitoring Plan/Risk Management Plan
-Performs data analysis and drafts regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
-Contributes to the set-up of safety procedures and development of safety exchange agreements for co-development projects

IHRE QUALIFIKATIONEN:

-Life science degree (BSc, MSc)
-Vaccines and/or biotechnology industry experience preferred
-Extensive experience in clinical trials and postmarketing pharmacovigilance
-In-depth knowledge of the pharmaceutical and/or biotechnology industry in Pharmacovigilance functioning as a Pharmacovigilance specialist
-Strong investigational event and aggregate assessment/review/documentation skills
-Working knowledge of US/EU/APAC regulations and ICH guidelines
-Experience in communicating with the FDA, EMA, and other global health authorities
-Sound working knowledge of MedDRA coding
-Understanding of pharmacovigilance-related information systems
-Expert in Aggregate Report preparation and review
-Excellent English written and verbal communication skills, additional languages (e.g., Spanish, Japanese, German) desired
-Leadership/managerial experience preferred

WEITERE QUALIFIKATIONEN:

Drug safety manager