Job title: Vigilance Process Expert
Company: Novartis
Job description: Job Description
100+ process improvement initiatives in Operational Excellence! We are continuously improving pharmacovigilance processes and deliverables across Chief Medical Office and Patient Safety, ensuring adherence to Novartis Policies and compliance with international regulations, supporting the organizational strategy while striving for an enhanced productivity, quality and better patient outcomes.
Your responsibilities include, but are not limited to:
- Author and maintain procedural documents for assigned processes and drive continuous improvement by alignment of relevant stakeholders globally and locally.
- Be involved in the creation and maintenance of training material and communications for Novartis group and third party associates.
- Perform impact assessments on emerging regulations and ensure ongoing compliance to global regulatory requirements.
- Support 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 the Compliance & Quality function to produce compliance re-ports 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, develop-op 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), contribute to 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 to CMO&PS associates and other global line functions on regulatory requirements.
Minimum requirements
- PharmD, MSc degree in life sciences or equivalent.
- Minimum 2 – 4 years of experience in the pharmaceutical industry, particularly pharmacovigilance. Experience in medical device vigilance desirable.
- Experience of leading working groups. Procedural document writing experience
- Strong presentation and communication skills, and ability to operate effectively in an international environment and across Global Line Functions
- Strong organizational skills
- Ability to mentor; Fluency in English. Knowledge of other languages desirable.
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, 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!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Functional Area
Research & Development
Division
Global Drug Development
Business Unit
CMO & PATIENT SAFETY GDD
Employment Type
Regular
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.
Shift Work
No
Early Talent
No
Expected salary:
Location: Hyderabad, Telangana
Job date: Fri, 08 Jul 2022 05:32:49 GMT
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