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Pharmacovigilance Specialist

3 months ago

Pune, Maharashtra, India TransPerfect Full time

The Pharmacovigilance Specialist collaborates with the Lit Search/Medical Writing team and clients to analyze and report on safety findings, within the context of patient safety and efficacy against our clients' drugs and products.

The Pharmacovigilance Specialist ensures effective and clear documentation and communication of safety information, to share with clients directly, or report directly to health authorities, globally.


DESCRIPTION

  • Perform various tasks in support of our clients' clinical research including: adverse event analysis and processing
  • Preparation of safety reports for submission to various health authorities
  • Maintain data integrity and promote audit compliance by following Good Documentation Practice (GDP) standards
  • Safety document or data analysis
  • Adherence to project timelines, with proactive communication to project managers and clients, as needed
  • Understand and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and Standard Operating Procedures (SOPs)
  • Leverage internal data systems and tools to efficiently maintain data and reporting processes to reduce manual data retrieval
  • Recommend operational process improvements, both within the department and division-wide
  • Continually remain apprised of the constantly changing landscape of the healthcare industry and any potential impacts it may have to our business and our clients
  • Analyze stakeholder complaints related to safety reporting, address in real time, and discuss with project managers and/or clients to mitigate risk and implement/drive realistic solutions
  • Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor

REQUIRED SKILLS

  • 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
  • Client-facing
  • Excellent written and oral communication skills
  • Extensive knowledge of English grammar and spelling, as well as medical terminology
  • Knowledge of Good Clinical Practice (GCP), GDP, and International Conference on Harmonization (ICH) guidelines

REQUIRED EXPERIENCE AND QUALIFICATIONS

  • Medical experience and 2-3 years' drug safety experience
  • Doctor of Pharmacy (Pharm D), or Doctor of Medicine (MD) an accredited institution

DESIRED SKILLS AND EXPERIENCE

  • Knowledge of Common Toxicity Criteria (CTC) and/or MedDRA coding preferred
  • Experience in working with collaborative, cross-functional teams
  • Proficiency in Word, PowerPoint, Excel, Outlook, EndNote, and scientific databases including PubMed, Embase, etc.
  • Drug development/clinical trial experience