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Pharmacoviglance - Team lead Level - Aggregate Report

 golden opportunities pvt ltd

  • 3 - 5 years
  • Chennai
  • Applicants: 0
  • Views: 31
  • Posted: 08 10 2020
  • Full Time

Job Details

Experience: 3 - 5 years

Qualification: B.Pharm(Pharmacy)

Salary Offered: 2 - 4 Lakhs Annually

Functional Area: Health Care

Industry: Pharma, Biotech,Chemical,Research

Role: Bio - chemist

Job Location: Chennai

Gender: Male

Number of Vacancy: 5

Language: English, Hindi

Job Description

  • Pharmacoviglance Role at Team lead Levels- Aggregate Report
  • To assist physician in maintaining up to date knowledge of the client products assigned with focus on the safety perspective. This includes but is not limited to pharmacology indications safety and efficacy aspects and could potentially include clinical studies and epidemiological analyses.
  • To review clients surveillance strategy document and provide written confirmation verifying its understanding of changes.
  • To review aggregate case reports from Client designated safety database using relevant IS systems.
  • To review and assess literature bulletins and published meeting abstracts in accordance with business search strategy using relevant IS systems.
  • To identify safety signals from routine review of cumulative safety data and conduct initial evaluation of those signals and document outcome according to client specified criteria and requirements.
  • To document potential signal and related information in the signal tracking tool and maintain surveillance action log up to date.
  • To notify business surveillance team of any safety signal that it has detected that may require urgent evaluation and action.
  • To prepare summarize evaluate and document routine pre-SERM (Safety Evaluation Review Meeting) safety outputs from business dedicated safety database dedicated external databases (FDA AERS WHO Vigibase) and the published literature.
  • To participate in routine and ad-hoc team and project related meetings between Business and TCS like Handover Meeting Surveillance Meeting and Safety Management Team Meeting.
  • To prepare training material conduct and assess periodic and need based trainings as and when required.
  • To provide ongoing training on the updated surveillance strategy document routine signal management requirements product safety profiles and updated safety signal detection criteria for new hires.
  • To participate in conducting gap analysis and identify the remedial actions for the improvement of quality of deliverables as and when required.
  • To provide regular work update to lead-safety surveillance.

Skills Required

team leading

Key Requirements

  • Healthcare professional (B.Pharm M. Pharm PhD Life sciences Post-graduate) with 2-5 years of Pharmacovigilance experience in Pharmaceutical Company or Contract Research Organization (CRO) including safety surveillance or signal detection activities.
  • High level of medical competence with an ability to balance this with industry standards to achieve business goals.
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Email: info@gojobs.biz

Contact Person: HR

Web: www.gojobs.biz/

ABOUT COMPANY

Golden Opportunities, Is A Leading Recruitment And Training Firm. We Present Apt Opportunities To Meet Your Needs At The Right Time. We Ensure That The Aspirations Of Our Clients And Candidates Are Met With. We Have Built A Strong Multifaceted Client Base Across Verticals And Industries. We Have Been Serving The Needs Of Our Clients And Candidates For More Than A Decade Now. Our Consultants Make Sure That They Explore All Available Options To Match Your Requirement. We Ensure That A Candidates Needs Are Understood And A Right Career And Growth Plan Are Mapped Out. We Have Our Own Database Of Candidates To Find The Right Match For You. We Also Specialise In Developing Training Programs To Cater To The Needs Of Our Clients. Every Requirement Be It Recruitment Or Training We First Understand A Need And Then Deliver A Custom Solution To It.

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