155 countries around the world - that is where our medicines are available and another 30 new, innovative active pharmaceutical ingredients for different disease areas are in our pipeline.
We are committed to development - developing innovative compounds that serve the needs of a growing, aging population and developing new and innovative ways to reach people in low-income countries.
We invest in the most promising areas of science, in the most exciting innovations in the medical field, and in the most important needs of health care.
We are convinced that the best solutions are found in a team!
We are Novartis. Join us and help us reimagine medicine.
Within this very innovative environment we are currently hiring the
Patient Safety Project Excellence Manager (d/f/m) part time 50%
Management and monitoring of Patient-oriented programs (POPs) and coordination of the local implementation of Risk Management Plans (RMPs) as well as management of safety aspects of Digital Engagement Assets (DEAs) and Social Media listening programs (SMLPs) to ensure compliance with Novartis global/local procedures, national and international regulations/ standards/guidelines for vigilance of Novartis group marketed and investigational products (drugs and devices)
Responsibilities include but are not limited to:
• Support the Graduated Plan Officer / Patient Safety Responsible (PSR) in the timely and correct implementation of the pharmacovigilance activities defined in the RMP
• Work close together with other local/global Patient Safety associates, RMP managers, global RMP office, Marketing, Medical and Regulatory Affairs to ensure adequate fulfillment of RMP requirements.
• Train and support the POP program owners, ESPs or other involved personnel during the whole program conduction to ensure POPs performance is in line with internal and external requirements.
• Ensure regular quality controls and deviation management during the conduct and after the closure of a POP (reconciliation, source data verification (SDV), integrity and correctness of database records) according to the applicable Novartis standards and vigilance guidelines
• Manage local PV tasks for SMLP/DEAs together with other local/global Patient Safety associates, SMLP and DEA Owners as well as Digital Champions to ensure accurate conduction of programs according to PV requirements
• Provide PV training to SMLP and DEA Owner, ESPs or other personnel involved in the conduction of a SMLP / DEA
• Ensure global Guidelines regarding SMLP/DEA are implemented locally taking special local requirements into account
• Survey and monitor national vigilance regulations and provide update to global Patient Safety organization and other affected global departments
• Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements
• Organize, implement and participate in Novartis SDV, audits and official inspections and ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections
• Play an active role in cross-functional teams on safety matters of special projects and RMP management relating to investigational and marketed drugs and devices
What you’ll bring to the role:
• Health Care Sciences Professional (preferably physician (including veterinarian or dentist), pharmacist or natural scientist), ideally with MD/PhD
• At least 3 years’ experience in drug safety, clinical research, medical device management, quality management, medical information management , compliance management or closely related areas of responsibility
• Basic knowledge of national and international regulations for pharmacovigilance
• Knowledge of pharmacological and medical terminology.
• Basic knowledge of physiology, pharmacology, clinical study objectives, and the drug development process
• Quality oriented with a good knowledge of relevant GxP-guidelines and relevant Novartis internal guidelines and regulations
• Good communications, interpersonal and negotiation skills
• Good organizational, planning and project management skills
• Ability to work independently or as part of a team and without close supervision
• Ability to work under pressure and meet tight timelines
• Fluent in both written and spoken English and German
b>Why consider Novartis?
799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks. And where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis!
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
We are looking forward to receiving your detailed application at: www.karriere.novartis.de