Specialist, Pv

2+ years

Not Disclosed

Ahmedabad

15 June 14, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.

About Us: Baxter's Mission

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 build a place where we are happy, successful and encourage 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.

Your role at Baxter

As a member of Safety Operations Literature team within Global Patient Safety (GPS). This position serves as a subject matter expert for individual case safety reporting both in general and specific to scientific literature. 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 team to review, rectify and reconcile data.

What you'll be doing

Supervise quality of abstract review, article review, and individual cases processed by PV agencies through random QC of cases or through review of aggregate data.

Provide training to outsource vendor for Literature review and case processing. This includes coordinating new hire training and certification and ongoing training and feedback for existing vendor staff.

Process literature adverse event reports as needed as a part of a cross-functional team.

Interface and collaborate with other functional partners at 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 supervising related activities including CAPA and Quality Control Metrics.

What you'll bring

Bachelors or Master's degree in Pharmacy

Minimum 2 years patient care, or equivalent experience AND minimum 1 year experience required as Safety Review Specialist or proficiency in a Global Safety Database (e.g., ARISg, Argus)

Knowledge of multiple therapeutic areas equivalent position

Experience in pharmaceutical industry- Quality, Pharmacovigilance or Regulatory department

Excellent analytical & problem-solving skills

Excellent oral and written communication

Collaborative interpersonal skills to cultivate a team environment

Ability to work independently under deadlines and changing priorities

Able to multitask and prioritize changing workload every day

In-depth knowledge of worldwide and regional safety regulations

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law

EEO is the law - Poster Supplement

Pay Transparency Policy

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.