Pop (Patient-oriented Program) Governance

vor 5 Monaten

Nuernberg, Deutschland Novartis Vollzeit

766 million patients worldwide are treated with Novartis medicines every year. Our focus is on the patient, this is why we conduct more than 180 patient-oriented programs in Germany every year. These programs help us to better understand the needs of our patients and customers and thereby make our therapies even better.
We are convinced that the best solutions are found in cooperation; become part of our team now
Job purpose:
Management and monitoring of Patient-oriented programs (POPs) and support of the coordination of the local implementation of Risk Management Plans (RMPs) as well as the 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).

**Your tasks include**:
Your responsibilities include, but not limited to:

- 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 global Guidelines regarding POPs are implemented locally taking special local requirements into account.
- 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.
- Support the Graduated Plan Officer / Patient Safety Responsible (PSR) in the timely and correct implementation of the pharmacovigilance activities defined in the RMP
- 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 POP expert teams and on safety matters of special projects.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

**What you’ll bring to the role**:

- Health Care Sciences Professional (preferably physician, pharmacist or natural scientist), ideally with MD/PhD
- Physician (including veterinarian or dentist), pharmacist or natural scientist: at least 2 years’ experience in drug safety, clinical research, medical device management, quality management, medical information management, compliance management or closely related areas of responsibility
- Fluent in German and English, both written and spoken
- 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.
- 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 in a fast paced environment and meet tight timelines

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Novartis
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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