Associate Director - Patient Safety Physician (gn): Oncology

Über uns For a globally leading (bio)pharmaceutical company, we are

assigned to recruit an Associate Director Patient Safety Physician

(gn) for the therapeutic area Oncology. 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. In this role, you will

work closely with the clinical development department and will be

involved in a very strategic and global function. 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.

Keeping senior management apprised of the safety profile of designated

drugs and suggesting PV/RM actions Profil Medical degree with clinical

and/or clinical research experience. Proficient knowledge in

pharmacovigilance (PV) and a comprehensive understanding of PV

regulations in major markets. Experience in clinical development and

involvement in regulatory submissions would be advantageous. Clinical

or research experience in oncology are a big plus. 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. Wir bieten highly strategic and

development-related role high-impact on the development of new drugs

global and intercultural work environment Kontakt Sollte diese

Position Ihr Interesse geweckt haben, freue ich mich auf Ihre

Kontaktaufnahme und ein erstes Kennenlernen. Ihre Beraterin für diese

Position ist Frau Dilsâd Babayigit. Bitte schicken Sie Ihren

aktuellen Lebenslauf per Mail an apply.job.24480764@hokifyjob.com oder kontaktieren

Sie mich gerne per Telefon unter der Rufnummer 089 7263 210-00.