Must have worked on drug safety (pharmacovigilance) team and understand the end-to-end PV lifecycle.
Must understand concepts of ICSRs, Periodic reports and Signal Management process.
Serve as subject matter expert and lead instructor providing highly complex and expert guidance on RMP and aRMM process.
Understand various stakeholders in management of RMP and aRMM process.
Define and design process charts, follow swim-lane diagrams of process and its variations related to RMP and aRMM process.
Stay updated with client nuances, regulatory changes, and newer advances in RMP/aRMM regulations and guidelines.
Must be able to discuss with business users on the gaps, pain-points and suggest obliteration of NVA steps in the process.
Must directly interact with customers, understand the unmet needs, and transpire them into solutions for BRM/RMP and aRMM process.
Work with the customers to prioritize problems or themes to reach the outcomes.
Work with both UX and Development to understand design or technology implications in solution ideas.
Effectively communicate and execute the product roadmap that delivers against the vision and communicate product launches and timelines to key internal and customer stakeholders.
To develop new features and within this product and prioritize the requirements by formulating product roadmap.
To be able to develop the needed unmet services within the RMP space.
Any ad hoc duties or projects in line with the development of the business.
Work closely with Product Management to create and maintain a product backlog according to business value or ROI.
Lead the planning product release plans and set the expectation for delivery of new functionalities.
Provide an active role in mitigating impediments impacting successful team completion of Release/Sprint Goals.
Research and analyse market, the users, and the roadmap for the product.
Develop and maintain appropriate tracking and reporting of product performance to evaluate future investment.
Follow our competitors and the industry.
Keep abreast with Agile/Scrum best practices and new trends.
Required Qualifications
Bachelor’s degree in science or engineering.
Senior level (minimum Director) experience within the Pharma industry or as a Regulatory inspector (preferred), plus experience of consulting.
Ability to interpret and present highly complex and strategically significant information.
Mastery knowledge of regulations and guidance related to the products within the portfolio of services.
High level of technical aptitude.
Should be able to coordinate with the various teams – development, testing, product owners etc.
Previous successful relevant account management or technical experience.
Sound time management, organisational skills, and attention to detail.
Excellent communicator both written and spoken with great presentation skills verbal and written communication skill.
Knowledge of PV systems (Argus, ArisG etc.) will be an added advantage.
To apply for the above position, please send your word resumes to careers@vitrana.com by specifying the Job Code.
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