Subject Matter Expert - Pharmacovigilance Job in Arisglobal

Role: SME - Pharmacovigilance
Experience: 7 to 12 Years
Job location: Mysore (Karnataka)

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

• Masters or Bachelors Degree in Pharmacy or Medicine with 7+ years of experience
• 6+ 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