Subject Matter Expert - Pharmacovigilance

Date: May 5, 2021

Location: KA, IN

Company: ArisGlobal

About the candidate:

Education & Experience : (State the minimum acceptable qualifications w.r.t. education, experience, certification)

  • Masters or Bachelors Degree in Pharmacy or Medicine with 10+ years of experience
  • 5+ years of experience in Drug Development domain - Pharmacovigilence and Safety is essential
  • Would have used software solution as part of Pharmacovigilence and Safety experience

Skills : (Technical Skill / Non Technical Skills)

  • Excellent Communication skills
  • Recent trends in domain
  • Product Lifecycle Management process knowledge
  • Software Development Life Cycle Process Knowledge
  • Business analysis skills

Competencies : (Competencies requirement for the candidate to perform the task)

  • Experience in working with customers to understand their business and convert those into high level requirements
  • Complete understanding of overall Pharmacovigilance operations associated with medicinal products including the entire adverse events process which may include Safety data collected from clinical trials
  • Experience in Managing and processing expedited adverse events to the required standards and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines
  • Experience in preparation of individual case reports to determine regulatory reporting responsibilities; assessing benefit-risk; assessing potential drug-related toxicities; assessing potential safety signals; writing individual case assessments and interpreting aggregate safety data; determining potential impact of safety data on product labeling or development status of investigational compounds.
  • Experience in preparation and management of medical safety documents, e.g. PV plans and risk assessment documents, submitted to FDA; responses to FDA inquiries regarding product safety; and assists with FDA inspections within Drug Safety.
  • Experience in communicating potential safety issues

Personal Traits : (Personality attributes required like initiative, perseverance, problem solving, critical thinking, etc.)

  • Innovative and passion for creating value
  • Ownership driven
  • Dependability & Accountability
  • Proactive
  • Motivator/Mentor
  • Good Interpersonal Relations
  • Good comprehension, analytical and presentation skills

Roles & Responsibility : (Main areas of responsibility and roles to be performed)

  • Will work very closely with Software Product Unit management to define strategy for Pharmacovigilance & Safety solution
  • Identifies the new features to ensure that products have highest value functions many of which are differentiators against competition
  • Works with PTM to develop MRD and supports in the development of RD, UI, etc. Stays involved through the development cycle
  • Will support Sales to in product positioning through superior value proposition and enhances consultative selling efforts
  • Works with PMM to build the required collaterals
  • Will be final reference point on any functionality related clarifications
  • Will help PTM to in prioritizing the backlog based on strategy for the products
  • Will steer the roadmap discussions during Product Steering Committee meetings and get the approval
  • Will review the Requirement Documents (RD) and approve them
  • Will provide the Business scenarios for end to end testing of the solution 
  • Will support in reviewing the best pharmacovigilance practices document
  • Will understand the regulations and keeps update date with the regulations
  • Will support Customer Working Group initiatives whenever needed