Pharmacovigilance Drug safety Associate Jobs for All Lifesciences Candidates

Navitas Life Sciences Hiring Notification for Pharmacovigilance SAFETY ASSOCIATE – I/II At Bangalore Location

Location : Bangalore, India

Eligible Qualification : Graduate or Post-Graduate degree in Life Sciences, Pharmacy, Medicine, Dentistry, Allied Health Sciences, and any other additional related courses

Role : Associate Pharmacovigilance and Safety

Job type : Full Time
Date posted : 13 Jun 2022

Job Description : We are currently seeking a Safety Associate I/II to support our work with Aggregate Reporting, Signal Management, and Risk Management Plans. Within the role you will:

Aggregate Reporting

  • Conduct the authoring and review of Aggregate Safety Reports (i.e. DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports) and any other aggregate reports as per the requirement of the project
  • Review Aggregate Safety Data from the database and generate Line Listings (LL) and Summary Tabulations (ST) and include the LL and ST in the appropriate template.
  • Analyze safety and regulatory data provided by the client and prepare complete Aggregate Reports according to the client’s requirements.
  • Perform literature screening for inclusion of significant safety articles in the respective section of aggregate reports
  • Compile benefit-risk evaluation sections provided by medical reviewers, as applicable.
  • Ensure compliance with internal and external timelines
  • Address comments from internal and external/client reviewer
  • Finalize reports as per client requirements
  • Participate in internal and external audits and inspections by clients and health authorities.

Signal Management and Risk Management Plans

  • Conduct screening, data mining, and frequency tabulation for potential signals including signal estimation using appropriate signal detection tool as per the client requirement.
  • Generate line listings and summary tabulations from Argus/client safety database.
  • Draft Signal detection, validation, assessment, and benefit-risk analysis and prioritization of signals by reviewing available data.
  • Ensure compliance to appropriate signal SOPs, conventions, and guidelines for all activities performed.
  • Track identified signals from the regulatory and internal signal detection process and monitor the status of signals: potential signals, open signals, refuted signals, and validated signals.
  • Develop Risk Management Plans and associated activities as per Navitas Life Sciences/client-specific SOPs

Desirable Skills and Experience

  • Sound knowledge of the PV domain and working experience in Aggregate Reporting, Signal Management, and Risk Management Plans
  • Good knowledge of DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports
  • Excellent computer skills and knowledge of MS Office including Word, Excel, and PowerPoint
  • Excellent organizational and time management skills
Pharmacovigilance Drug safety Associate Jobs for All Lifesciences Candidates
Navita Lifesciences – Pharmacovigilance Drug safety jobs

4 thoughts on “Pharmacovigilance Drug safety Associate Jobs for All Lifesciences Candidates”

  1. Hi myself Ranganath, I’m B. Pharmacy fresher, I completed my B. Pharmacy on 2021.I am interested in pharmacovigilance. So please give me chance to prove myself. My contact number:7825980838
    Best regards
    Ranganath. V
    Thank you

  2. Hai Myself Syed vazeer completed In 2021.Intrested in PV.Present i am working as a coder in optum project with a quality of 96%.Please give me a chance I will prove myself.
    Syed vazeer

  3. Hii, My name is Pratishtha Sarathe.I am graduate fresher passout year 2021 , I am interested to work in Pharmacovigilance department, So kindly respond to my application sir/ mam to prove my skills knowledge and learnings to your company. Your,s regards. Pratishtha Sarathe. Contact number 9691920644

  4. Hello,
    I am Pooja Tarde and I have completed M. S. Pharm from National Institute of Pharmaceutical Education and Research, Ahmedabad. I am interested to work in PV. So please give me a chance to express my skill.

    Thanks & Regards,
    Ph: 8600475108

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