Beschreibung
* Definition of the strategic direction of medical safety* Preparation of the risk-benefit profile and provision of a safety science leadership
* Ensure oversight of the emerging safety profile of the product
* Medical review of safety reports, signal detection and assessment, risk-benefit assessment and risk management throughout the life cycle of the product
* Ensuring that safety signals are immediately identified and appropriately communicated
* Development of high-quality contributions to medical safety
* Ensuring that all negotiated and agreed results and deadlines for these teams are met
* Development of the safety strategic input for submission documents such as Integrated Safety Summary, Clinical Safety Summary, Clinical Review and Safety Update Reports
* Representation of the GPS on safety aspects for the product
* Participation in meetings of regulatory authorities and cooperation with colleagues from partner companies
* Assistance with audits and inspections by the supervisory authorities
* If required: Provision of product- or TA-specific training for GPS and safety training for colleagues
Location: Remote during Covid-19, followed by on-site
* Several years of medical experience as a physician, preferably clinical experience in the relevant therapeutic area
* Broad industry experience (minimum 5 years), preferably including both clinical development and pharmacovigilance experience
* Excellent knowledge of the pharmacovigilance regulations/guidelines and its application for activities related to assigned product(s)
* Excellent knowledge of product development process and experience of cross-functional teamwork
* First-hand experience in handling safety issues related to known target organ toxicities (e.g. hepatic, renal, hematological) and good medical understanding of the relevant therapeutic area(s)
* Expert knowledge of aggregate data analytics and understanding of related sciences such as predictive modelling, epidemiology, health outcomes and biostatistics
* Preferentially prior experience with NDA/BLA or equivalent regulatory submissions or working experience from a Regulatory Agency on reviewing submission files
* English business fluent, German nice to have
Schlagwörter:
medizinische Sicherheit, Führung, safety, pharma, drug, Medikamentenentwicklung, Arzneimittelentwicklung, Pharmakovigilanz, Arzneimittelsicherheit, Sicherheit, Medikamentensicherheit, pharmazeutisch, Pharmazeut, Biologe, Freiberufler, freelance
Kontaktperson: Personalreferentin Frau Julia-Elisabeth Kratz
FERCHAU GmbH
Niederlassung Darmstadt
Rösslerstr. 88
64293 Darmstadt