Senior Manager Regulatory Information Management Systems

Senior Manager Regulatory Information Management Systems (Veeva Vault)

Mumbai or Vadodara, India (hybrid role: 3 days office, 2 days home per week)

Salary: Competitive + Benefits + Bonus

If you are an agile, committed and data-driven Veeva Vault RIMS expert, with experience in global pharmaceutical regulatory affairs, then we want to hear from you.

Join us to help improve peoples' lives and make healthcare better for everyone!

About Pharmanovia:

Pharmanovia is a dynamic, fast-growing international pharmaceutical company with a portfolio of over 20 brands across more than 160 markets. Our mission is to improve patient health globally through the revitalisation of niche, tried-and-trusted medicines.

Our core behaviours are:

• We act decisively but we never compromise on quality.
• We keep our promises and do as we say.
• We value our heritage and foster an entrepreneurial spirit.
• We reinvest in our future - in our products, our brands, and our people.
• We give back to our communities.

Since its inception in 2013, Pharmanovia has grown consistently year on year, focusing on delivering high-quality branded prescription medicines to patients, prescribers, and healthcare providers across the world. Our growth has enabled the company to reinvest in its products, brands, people, and to give back to its communities. A people business with a strong, supportive culture that encourages innovation and entrepreneurial spirit, our team comprises over 300 employees and 29 nationalities, operating from offices in the UK, Denmark, Netherlands, Switzerland, Italy, Spain, Germany, U.A.E., India, China, Australia and Singapore.

We are an agile, committed, and innovative global specialty pharma business and a preferred partner for innovator pharma companies, instigating a paradigm shift in the life cycle management of iconic medicines. We seek to extensively engage with clinical communities to communicate product improvements and prioritise environmental, social, and governance considerations across the business and workforce.

About the role:

As Senior Manager, Regulatory Information Management Systems you will be responsible for managing, configuring, and maintaining the Veeva Vault platform to support the regulatory publishing and RIMS maintenance activities of Atnahs' markets within Pharmanovia.

Veeva Vault is a cloud-based content management platform specifically designed for the life sciences industry to manage documents, data, and processes. Our regulatory department is responsible for providing regulatory strategic advice and life cycle maintenance for the portfolio, globally, and support with new product development initiatives.

The Regulatory department has an ethos of continuous improvement. This, along with the rapid growth of the business, leads to a varied and dynamic working environment.

Main responsibilities & duties:

• Platform managed services

• Veeva Release Management - planning, impact assessment, implementation, validation and testing, documentation, in coordination with Veeva
• Training sessions and demos to the Pharmanovia team, following Veeva releases impacting the end user

• Incident management

• Day to day management and resolution of incidents
• Coordinating with Veeva for any platform or product level issues
• Propose lean processes to reduce and minimise the ticket issues raised by the team by up to 20% through training and trend analysis, subject to user adoptability and implementation by Pharmanovia

• Change management and internal release management

• Configure changes that are permissible to be implemented, such as workflows, lifecycle states, security, CVs

• Reporting and dashboards

• Creation of new reports, updates to existing reports as deemed necessary and/or on request from Pharmanovia
• Creation of dashboards, updates to existing dashboards as necessary and/or on request from Pharmanovia
• To work methodically with a keen eye for detail ensuring any data anomalies are highlighted

• Access management

• Control of access management of end user aligned with governance model for data management

• User adoption services to support continuous user adoption of Vault RIMS functionality

• Support on implemented functional processes within Pharmanovia Vault, either through checklists or work instructions

• Training

• Conduct regular monthly training with Veeva users on gaps/deficiency areas identified
• Providing ad hoc and on demand training

• Data management services

• Manage creation and update to foundational data [Product, Product Family, Product Variant, Packaging] as per the defined data standards
• Monitor and manage data quality within Vault proactively, based on pre-defined KPIs, identify corrective and preventive actions, agree with Pharmanovia stakeholders and support the implementation of data corrections
• Manage volume data extraction requests from Vault and content & data upload requests into Vault
• Management of all electronic publishing systems and peripheral components which support those system, and assisting with the development and maintenance of procedural and operational documentation related to Atnahs' regulatory technology platform(s)
• Cleansing large data sets from source destination in support of a system migration and to maintain a logging system / data quality plan
• Assign appropriate taxonomy and metadata to source data where required
• Maintain naming conventions and structure protocols and validate accuracy

• Support continuous improvement opportunities

• Quarterly updates with measurable improvements/opportunities that end users could utilise to increase efficiencies

About you:

Candidates with around ten years of experience in regulatory information/data systems management, ideally on the Veeva Vault platform within the pharma/CRO/CMO environment, should have the skills and experience required for the role. We are also looking for:

• Bachelor's degree in scientific/health field, Computer Science, Information Technology, or a related field
• Relevant certifications in Veeva Vault administration or related areas are a plus
• Full professional proficiency in English (written and verbal)
• Excellent knowledge of Veeva Vault platform, or similar document management systems in configuration and support, gained within pharma, CRO, CMO or similar organisation
• Strong knowledge of MS Word, Excel, PowerPoint, Project and Outlook
• Experience with cloud-based platforms and SaaS preferred
• Basic understanding of software validation and testing, as well as Agile methodology
• Strong understanding of documentation management concepts and practices, particularly in the life sciences industry
• Proficiency in system configuration and customisation
• Experience in compliance and maintaining product lifecycle databases and RIM systems
• Experience in GxP topics is desirable
• Strong attention to detail in composing and proofing materials, establishing priorities, scheduling and meeting deadlines
• Ability to independently resolve problems and skilled at troubleshooting
• Ability to work in a cross-functional team in a fast-paced environment, with demonstrated ability to juggle multiple competing tasks and demands
• Excellent communication skills, with stakeholder management skills

What we offer:

We offer a competitive salary plus bonus and rewards package including holiday, health & wellbeing program, employee recognition awards, social events, pension scheme and hybrid working.

By applying for this role, your details will be sent to Ortolan People, who are engaged to provide recruitment support in processing applications. We will endeavour to respond to all applicants within three working days. Occasionally for roles with a very high volume of applicants, this may not be possible.