Senior Consultant
Mexico City, Mexico
hace 6 días

Subject Matter Expert Role :

SPOC for all subject matter related issues and queries to the managers. Responsible for providing guidance and support to the project managers in understanding any domain related knowledge related to PV.

Domain and Project related Trainings :

  • Point of contact for any domain or project related trainings. Responsible for creating a training plan that covers all aspects related to domain knowledge
  • Responsible for creating training material relevant to PV / Compliance practice
  • Project Enhancements and Automation :

  • Work with the Engineering team to drive enhancements and automation to reduce effort and improve quality. Monthly report to be created highlighting the efficiency and quality gains using enhancements / automation
  • Work with the Ontology technology team to drive efficiency using Ontology
  • Lean / Kaizen approach to problem solving Apply Lean / Kaizen methodologies to solve problems / issues
  • Project and Program Audits :

  • Work with the audit team to create and perform monthly process audits for the major programs within the PV team
  • Work on the documentation of process and practices to make the team audit ready
  • Best Practice sharing Highlight best practices across GDC teams
  • Enable pharmacovigilance / adverse events (PV / AE) tracking business deals by supporting the onshore teams in the sales cycle, through building / enhancing suitable collaterals for the practice, including pitch decks, proposals, project plans, audit plans, and SOPs
  • Liaise with the technology team to drive the PV / AE engagements successfully and leverage automation to enhance productivity as well as quality
  • Use relevant medical experience in determining AEs of drugs / medicines for specific diseases / therapeutic areas
  • Prepare the team for pharma company PV audits and to successfully undergo these audits
  • Establish processes for training as well as certifications required for the PV practice
  • Assist in other project management activities as required
  • Responsible for creating training material relevant to PV / compliance practice
  • 7+ years of experience in pharmacovigilance (post-marketing surveillance experience is highly necessary as opposed to AE tracking in clinical trials)
  • Experience of driving the preparation for audits and successfully undergoing stringent audits by pharma companies as a PV agency / partner to a pharma company
  • Knowledge of and exposure to unstructured data / social media data would be a plus
  • High comfort level and affinity to using technology tools in the field of AE tracking
  • Social adaptability willingness to adapt to international cultures, work environments, and business processes
  • Knowledge of processing / reporting requirements of ICSRs and thorough understanding of EU and US legislations on AE reporting
  • Essential :

  • Sound safety knowledge of applicable good clinical practice (GCP), good pharmacovigilance practice (GVP), and International Conference of Harmonization (ICH) guidelines
  • Has hands on / practical experience in IRT , ARISg or Argus databases
  • Excellent communication and analytical skills
  • Desirable :

  • Related certifications / trainings such as client (pharma) AE certifications, DIA certifications, etc.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and customers
  • Has experience in people management
  • Educational Qualifications :

    MBBS, MD, M. Pharm , BPharm or any relevant HCP degree

    Languages : Fluent in English and Spanish . Preferable if any other European language is known.

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