Product Owner Pharmacovigilance (pv) Applications Job in Vitrana Inc.

Description

The Product Owner (PO) is directly accountable for the definition and delivery of a part of a platform/suite or module from a customer and regulatory market requirement point of view regarding content, prioritization, quality, and customer excitement for a given cost and time frame. The PO shall be responsible for a part of the platform/suite or module through the product life cycle from the definition to the phase-out.

The PO shall provide to the associated development teams with the priorities and expertise regarding the product and responsible for definition and delivery of a part of a product from a customer and market requirement point of view, working with one or several development teams.

Internal Interactions: Product Line Manager, Product Manager, Project Manager, Quality Manager, Development Team (e.g. Scrum Master, System Analyst, Architect, Developers, Testers), other stakeholders (e.g. Business Units), SCM (Enabling) & Customer Service teams, Technical Writers, etc.
External Interactions: Customers PV Head, PV Operations Managers, Subject Matter Experts, Business Users etc.

Responsibilities

• Elicit and collect stakeholder requests, while you define and prioritize Regulatory Requirements
• Analyse Regulatory Requirements (e.g. initiate and manage concepts for complex regulatory and market requirements)
• Derive, prioritize and communicate Software Requirements
• Create Software Requirement Specifications (i.e. problem part)
• Ensures user stories are captured in detail for development to start work.
• Coach/ support development team s questions and resolve conflict regarding features and requirements
• Analyse and decide complaints and charms
• Achieve commitments with and motivate development teams, assist development teams in attaining maximum effective sustainable pace for development
• Define product vision, roadmap, and growth opportunities and provide backlog management, iteration planning, and elaboration of the user stories.
• Ensure quality by evaluating results of iterations and either approve/ accept or reject results based on acceptance criteria
• Plan and prioritize product backlog and development for the product. Lead the planning product release plans and set the expectation for delivery of new functionalities.
• Support effort estimations of development teams
• Analyse change request entries and prioritize with other product backlog items
• Coordinate cross-feature-area development with peers to facilitate prioritized product development
• Deliver input for project management, support roll-out of the system, presentation, workshops, training for sales and customer demos.
• Hands on technical documentations such as Requirement Specification Document, Business Requirement Document, SOW and so on.
• Provide an active role in mitigating impediments impacting successful team completion of Release/Sprint Goals.
• Keep updated with Agile/Scrum best practices and new trends.
• Ability to participate in client demos, probe questions, work towards building pipeline for future release.
• Research and analyse the market, the customers, and the roadmap for the product.

Requirements

• A Bachelors / master s degree in life sciences, engineering and / or MCA or equivalent.
• 10-12 years of experience as a Business Analyst or Product Manager or Product Owner for a minimum of 3 years.
• Desired knowledge & experience in healthcare market, drug development lifecycle, end-to-end pharmacovigilance lifecycle and regulatory affairs, medical review of safety reports.
• Product know-how and customer understanding: sound knowledge of Clinical and Healthcare IT, especially in adverse event management, healthcare industry standards like HL7, DICOM and IHE.
• Good understanding of software systems categorized as medical device, drug and vaccine with intermediate knowledge of veterinary-vigilance, cosmetic vigilance and evolving vigilance sciences.
• Basic understanding of Legal regulations and standards applicable for drugs, vaccines and medical devices, affecting all aspects of safety (i.e. FDA 21CFR820QSR, ISO 13485)
• Exposure to agile methodology, thorough experience in requirements engineering, usability engineering and feature definition activities.
• Product Lifecycle Management & Software development cycle experience.
• Possessing success skills Self driven and takes Initiatives, Decision making skills, Result orientation, Self-motivated and provides motivation and inspiration to the team, Strong Analytical and Problem-Solving Skills. Strong team player and networking skills. Strong written and oral communication skills. Strong interpersonal skills and mainly, a strong customer focus.