Sr Assoc, PVReq # JR - 032407 Location Ahmedabad, Gujarat Job Category Patient Safety Date posted 01/21/2021
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
This section focuses on the main purpose of the job in one to four sentences.
This position is a member of the Safety Operations team within Global Patient Safety (GPS). This position serves as a subject matter expert for individual case safety reporting both in general. Individuals will perform quality review of work performed by the PV outsource vendor providing instruction and training as needed. This position collaborates with others outside of Safety Operations to review, correct and reconcile data.
Essential Duties and Responsibilities:
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
Responsibilities include, but are not limited to the following:
- Interface and collaborate with other organizations within Baxter (e.g. Regulatory Affairs, IT, Legal, Customer Service, etc.) Collaborate with local and regional Patient Safety team members to facilitate the global exchange of safety information.
- Participate in compliance monitoring related activities including CAPA and Quality Control Metrics.
- Perform reconciliation activities with organizations both within Baxter and outside of Baxter.
- Represent GPS in broad, cross-functional or multi-divisional initiatives, and/or serve as project lead for departmental projects
- Serve as therapeutic area escalation contact for questions within GPS as well as those coming from outside GPS.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Medical and clinical knowledge
- Excellent analytical & problem solving skills
- Excellent oral and written communication
- Collaborative interpersonal skills to foster a team environment
- Ability to work independently under strict deadlines and changing priorities
- Able to multitask and prioritize changing workload on a daily basis
- In-depth knowledge of worldwide and regional safety regulations
- Ability to establish priorities for self
- Proficiency in a Global Safety Database (e.g., ARISg, Argus)
- Knowledge of multiple therapeutic areas
- Excellent skills in reading, understanding and assessing scientific literature
Education and/or Experience:
Include the education and experience that is necessary to perform the job satisfactorily.
- Active License (RN or Pharmacy)
- Experience in pharmaceutical industry- Quality, Pharmacovigilance or Regulatory department
- 2-3 years patient care, or equivalent experience AND
- Minimum 3-5 years’ experience required as Safety Reviewer or equivalent position.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.