PASSION FOR INNOVATION. COMPASSION FOR PATIENTS.

With over 120 years of experience and approximately 19,000 employees in more than 30 countries/regions, Daiichi Sankyo is dedicated to discovering, developing, and delivering new standards of care that enrich the quality of life around the world.
In Europe, we focus on two areas: The goal of our Specialty Business is to protect people from cardiovascular disease, the leading cause of death in Europe, and help patients who suffer from it to enjoy every precious moment of life.
In Oncology, we are driving innovation in solid tumours and blood cancers, founded on breakthrough science from our own labs in Japan. We aspire to create better tomorrows for people living with cancer and their loved ones.
Our European headquarters are in Munich, Germany, and we have affiliates in 15 European countries and Canada.
We are seeking a highly qualified candidate to fill the position:

PERSONAL SKILLS AND PROFESSIONAL EXPERIENCE:

• Bachelor’s Degree in a scientific, health care or related discipline required. Experience Qualifications
• 8 or more years of professional experience in Quality and clinical development in the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance
• Proficiency in ICH Guidelines, US and European regulatory requirements relevant to pharmacovigilance. Ability to provide interpretation and guidance for internal and external customers on GVP related regulations / guidelines (e.g., FDA, EU, ICH) and company procedures and policies.
• For GVP, proficiency in GVP Modules and regulatory requirements for pharmacovigilance and post-marketing safety
• Professional or other related function and familiarity with Oncology, Specialty Medicines and Companion Diagnostic products
• Exposure to and awareness of relevant regulations and guidance documents in the area of Good Clinical Practices, Regulatory Affairs, Clinical Development would be advantageous
• Proven experience with Health Authority Inspections, (e.g., FDA, HPFB, MHRA and other European regulatory agencies)
• International experience is a plus; but at minimum, experience working with diverse cultures and employees
• Expertise working within early development through Phase III and Pharmacovigilance studies preferred

SKILLS AND ADDITIONAL REQUIREMENTS

• Experience working both independently and as part of a global multifunctional team
• Ability to review comprehensive audit reports and write summary documentation for senior management and functional areas
• Proven organizational skills and strong ability to prioritize workload
• Detail oriented and commitment to seeing tasks through to completion
• Ability to handle high workloads, stressful situations, and deadlines