Sandoz pharmacovigilance job vacancies in Hyderabad as Aggregate Report SME
Job Description; 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.
job tittle; Safety Case SME
- Division; Novartis Technical Operations
- Business Unit; NTO SANDOZ TECHOPS
- Country; India
- Work Location; Hyderabad, AP
- Company/Legal Entity; Sdz Pvt Ind
- Functional Area; Research & Development
- Job Type; Full Time
- Employment Type; Regular
Your responsibilities include, but are not limited to:
- Supports monitoring of all aggregate reporting-related activities to facilitate oversight on Strategic supplier’s quality and compliance of deliverables
- Support coordination with global line functions to ensure information is received, analyzed, and incorporated into ARs as per the regulatory requirements
- Support audits/Inspections as Subject Matter Expert, and develop, monitor, and implement Corrective and preventative Actions (CAPA) to address safety findings
- Support audit and inspection readiness within the internal and strategic supplier teams supporting Aggregate Report writing
- Develop, contribute, and maintain guidance documents including providing inputs to PVA and other such safety management plans
- Train and mentor new PS associates and associates from other line functions. Support Patient Safety departments, Vigilance Agreement Partners (VAP), and medical safety to ensure that reports are accurately collected, evaluated and data-based
- Support the testing activities for related safety systems/IT applications. Support Operational Projects or database validation activities as required
- Identify any non-conformity with global procedures, processes, and regulatory requirements related to Aggregate Report management within Sandoz and strategic suppliers and handle them as per QMS processes.
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 for Novartis pharmacovigilance jobs
- Two years of pharmaceutical industry experience, preferably pharmacovigilance.
- Knowledge of drug safety regulatory requirements and general project management including at least one year in Aggregate reports experience is desirable.
- Good professional verbal and nonverbal communication skills
- Strong negotiation and ability to operate effectively in a global environment and across-line functions
- Results-driven, self-starter with a proactive working style committed and accountable, the transparent working style also under pressure.
- Strong operational and project management skills
Sandoz pharmacovigilance job vacancies in Hyderabad as Aggregate Report SME APPLY HERE
Sandoz pharmacovigilance job vacancies in Hyderabad as Aggregate Report SME