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Junior Pharmacovigilance Specialist

4 weeks ago

Pune, Maharashtra, India TransPerfect Full time

OVERVIEW:

The Junior Pharmacovigilance Specialist collaborates with the PV Solutions production team to analyze and report on safety parameters, within the context of patient safety against our clients' products, and in line with client requirements for case review.

DESCRIPTION:

  • Perform various tasks in support of our clients' clinical research including adverse event analysis and processing
  • Prepare safety reports for submission to various health authorities
  • Maintain data integrity and promote audit compliance by following Good Documentation Practice (GDP) standards
  • Adhere to project timelines, with proactive communication with Team Lead and Project Managers, as needed
  • Understand and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and Standard Operating Procedures (SOPs)
  • Analyze stakeholder complaints related to safety reporting, address in real time, and discuss with Project Managers to mitigate risk and implement/drive solutions
  • Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor

REQUIRED SKILLS:

  • Knowledge of Common Toxicity Criteria (CTC) and/or MedDRA coding
  • Knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and International
  • Conference on Harmonization (ICH) guidelines
  • Proficiency in Word, PowerPoint, Excel, Outlook, EndNote, and scientific databases including PubMed, Embase, etc.
  • Excellent written and oral communication skills in English
  • Strong attention to detail and adherence to SOPs and client specifications

REQUIRED EXPERIENCE AND QUALIFICATIONS:

  • Minimum Bachelor's degree in pharmacy or Master degree in Life Science
  • Experience (Preferred but Not Mandatory)
  • 1+ year in Pharmacovigilance (for experienced candidates).
  • Medical or healthcare-related experience is a plus
  • Recent graduates with a strong academic background and interest in drug safety/pharmacovigilance are encouraged to apply
  • Ability to work in collaborative, cross-functional teams (internships/academic projects may be considered)

DESIRED SKILLS AND EXPERIENCE:

  • Drug development/clinical trial knowledge
  • Creative thinker – Curious and unafraid to ask questions
  • Hard worker – Industrious and diligent in everything you do
  • Innovator – Willing to initiate changes and introduce new ideas
  • Team player who collaborates effectively