DAS UNTERNEHMEN
For a globally leading (bio)pharmaceutical company, we are assigned to recruit a (Senior) Patient Safety & PV (gn) Physician for the therapeutic area Inflammation.
Your primary focus will revolve around orchestrating the global initiatives for Patient Safety and Pharmacovigilance (PSPV) and Risk Management (RM) pertaining to compounds at various stages of development, mainly late stage and post-marketing. In this role, you will work closely with the clinical development department and will be involved in a very strategic and global function.
IHRE AUFGABEN
* Crafting proactive, patient-centric RM strategies tailored to designated compounds.
* Overseeing and executing all PV activities pertinent to assigned drugs, encompassing database setup, continual safety monitoring, and addressing safety concerns.
* Engaging in cross-functional collaboration with departments such as Clinical Development and Global Patient Engagement to devise patient-centric benefit-risk evaluations for developmental compounds.
* Collaborating with Global Epidemiology and Medical Affairs to design safety-oriented post-authorization studies.
* Analyzing clinical trial safety data for incorporation into clinical trial reports and regulatory submissions.
* Providing medical-scientific insights into regulatory documents, including PSURs, DSURs, RMPs, and Clinical Overview Statements.
* Chair multidisciplinary Benefit Risk Teams
* Keeping senior management apprised of the safety profile of designated drugs and suggesting PV/RM actions
IHR PROFIL
* Medical degree with clinical and/or clinical research experience in the according therapeutic area.
* Proficient knowledge in Patient Safety strategies and a comprehensive understanding of PV regulations in major markets.
* Experience in clinical development and involvement in regulatory submissions would be advantageous.
* Excellent medical-scientific understanding of your indicational area(s)
* In-depth understanding of the pharmaceutical industry, future trends and developments in pharmacovigilance
* Practical understanding of PV regulation in major markets and respective need for compliance
* Strong interpersonal and communication skills.
* Strong ethical sense coupled with a focus on quality and patient safety.
* Excellent English language skills, both written and verbal.
BENEFITS
* highly strategic and development-related role
* high-impact on the development of new drugs that are to be submitted
* global and intercultural work environment