Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 1 billion people globally and we are finding innovative ways to expand access to our latest treatments. About 125 000 people of more than 140 nationalities work at Novartis around the world.
Job Responsibilities
- Monitors and audits the company’s drug, biologics or medical devices surveillance program including the intake, evaluation, processing and follow-up on adverse reports. Participates in the resolution of any legal liability and in complying with government regulations. Ensures accurate receipt, maintenance and assessment against product labeling.
- Reports events or reactions as required by regulatory agencies including adverse events data from clinical trials, spontaneous or solicited sources, periodic and experience reports. May provide trending and safety signal detection and assessment. Supports all clinical trial activity and post marketing.
- End to end management of assigned pharmacovigilance processes across Novartis Divisions.
- Responsible for ensuring compliance to global regulatory requirements with maximum efficiency.
- Lead assigned cross functional patient safety projects
- Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally.
- Develop and maintain training material and communications for Novartis group and third party associates.
- Support impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements.
- Lead assigned process improvement initiatives including IT projects/systems (leading enhancements and managing releases).
- Analyze the impact of other process and organizational changes.
- Work in collaboration with other functions to produce compliance reports and complete quality checks to monitor regulatory compliance as well as compliance to internal requirements. In the case of any delays, investigate the root cause and develop and implement corrective and preventative actions. Measure effectiveness of actions taken.
- Act as a subject matter expert during audits and inspections (e.g. FDA and EMA), lead the preparation of responses to findings and the development and implementation of corrective and preventative actions.
- Resolve queries from other functions and Country Organizations (COs) related to assigned processes and act as a consultant on regulatory requirements.
- Work jointly with other functions (like Compliance & Quality and Process Compliance & Risk Mitigation) to perform metrics trend analyses, generate knowledge and mitigate any identified risks.
- Mentor and train new starters.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Minimum requirements
- Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experience.
- At least 3 years experience in Drug Safety OR at least 5 years experience as medical advisor or study manager
- Excellent communications and negotiation skills
- Leadership and management skills
- Quality and focus oriented
- Computer skills
- Collaborating across boundaries
- Functional Breadth
The post RMP/ Patient Safety Manager at Novartis appeared first on Jobs in Kenya - http://jobwebkenya.com/.
The post RMP/ Patient Safety Manager at Novartis is republished from Jobs – Jobs in Kenya – http://jobwebkenya.com/
