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Sr Associate, PV

1.00 to 2.00 Years   Ahmedabad   25 Mar, 2020
Baxter India
Job LocationAhmedabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

Sr Associate, PV Req #: JR - 018275Location: Ahmedabad, GJ IN Job Category: Patient SafetyDate Posted: 3/23/2020 9:45:46 AMBaxter InternationalAre you looking for a career that matters We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.Summary:This position is a member of the 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 Safety Operations to review, correct and reconcile data.Essential Duties and Responsibilities:Responsibilities include, but are not limited to the following:

  • Monitor quality of abstract review, article review and individual cases processed by PV outsource vendor through random QC of cases or through review of aggregate data.
  • Provide training to outsource vendor for Literature review and case processing. This includes overseeing 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 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.
Qualifications:
  • 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:.
  • Active License (RN or Pharmacy)
  • Experience in pharmaceutical industry- Quality, Pharmacovigilance or Regulatory department
  • 2-3 years patient care, or equivalent experience AND
  • Minimum 1-2 years experience required as Safety Reviewer or equivalent position with experience specific to adverse event reporting from scientific literature.
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Keyskills :
new hire trainingadverse event reporting patient carepatient safety quality controlproblem solving customer serviceregulatory af

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