(Senior) Director Clinical Safety Oncology

vor 3 Wochen

Munich, Deutschland Daiichi-Sankyo Europe Vollzeit

**Passion for Innovation. Compassion for Patients.**:
**(Senior) Director Clinical Safety Oncology (M/F/x)**:
**The position**:
The (Senior) Director Clinical Safety Oncology is responsible for the overarching, global safety strategy and risk management activities, across the lifecycle, for his/her assigned oncology product (i.e. Antibody Drug Conjugation [ADC] oncology portfolio), with main focus on safety monitoring, evaluation, and risk management activities for EU post-marketing phase including EU MAA activities and overall global post-marketing activities including regulatory reports.

***Roles and responsibilities**:

- Provides strategic input on the development of post-marketing safety surveillance plan with global safety team for oncology products and delivers on the surveillance activities.
- Drives the safety strategy for the lifecycle management of designated product(s).
- Lead the development, maintenance and submission of relevant RMPs, PSURs for designated product(s).
- Engage signal detection/management and safety analysis activities in post-marketing phase.
- Oversee the effectiveness of overall risk management activities.
- Medical-scientific support of clinical trials, Post Authorisation Safety Studies (PASS) and non-interventional studies (NIS) concerning pharmacovigilance aspects
- Manages regulatory responses to emerging safety issues and provides strategies to address these in collaboration with global safety team.
- Supports as necessary clinical studies activities related to safety including safety relevant submission documents
- Represent CSPV in cross-functional meetings and work with Global Product Safety Lead to support leading a group of safety physicians/safety scientists, trains and develops them using individual development plans and routine day-to-day manager/employee interactions
- Contribution to maintenance of Pharmacovigilance Quality Management System including creation and maintenance of Standard Operating Procedures (SOPs) within Clinical Safety & Pharmacovigilance department

***Personal skills and professional experience**:

- University degree in medical science
- Experienced 5 to 8 years in Clinical Safety/Pharmacovigilance, 3 years experienced in Oncology Drug Development/Safety (Oncology specific medical knowledge is a must)
- Strong experience in oncology and in clinical safety
- Deep knowledge in International, European GCP, GVP laws
- Post-marketing and EU MAA/US NDA/BLA experience
- Fluent business English (oral and written)

**What we offer**:
**Working at Daiichi Sankyo**:
At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.

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