Subject Matter Expert - Pharmacovigilance Job in 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