30 Sep
|
Pharmanovia
|
Mumbai
30 Sep
Pharmanovia
Mumbai
RIMS Associate Manager | Mumbai or Vadodara, India | Hybrid: 3 days WFO, 2 days WFH
About the Company
Pharmanovia is a global speciality pharmaceutical company focused on innovative speciality medicines and trusted, established brands. Pharmanovia combines scientific, medical, regulatory, market access, supply chain and commercial expertise to bring medicines to patients. Together, they reflect a business built to meet patient needs today while helping shape better outcomes for tomorrow.
About the Role The RIMS Associate Manager (Veeva Vault RIMS) is responsible for managing, configuring with support extended 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. The role will provide platform managed services, incident and change management, reporting and dashboards, access management, user adoption and training, data management services, electronic publishing support and continuous improvement opportunities across Pharmanovia's regulatory technology landscape.
Key Responsibilities
Platform Managed Services
- Veeva Release Management – Planning, Impact Assessment, Implementation, Validation & Testing, Documentation, coordinating with Veeva.
- Training session & demo to the Pharmanovia team once Veeva releases have been released in Veeva and impact the end user.
Data Management Services
- Manage creation and update to foundational data [Product, Product Family, Product Variant, Packaging] as per the defined data standards.
- Monitor & Manage Data Quality within Vault proactively, based on pre-defined KPIs, identify corrective & 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 systems.
- This individual assists 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.
- To assign appropriate taxonomy and metadata to source data where required.
- Maintain naming conventions and structure protocols and validate accuracy.
Incident Management
- Day to day management & resolution of incidents.
- Co-ordinating 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 & Internal Release Management
- Configure changes that are permissible to be implemented, such as workflows, lifecycle states, security, CVs.
Reporting & Dashboards
- Creation of recent 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
- 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.
Continuous Improvement
- Support continuous improvement opportunities.
- Quarterly updates with measurable improvements/opportunities that end users could utilise to increase efficiencies.
Qualifications
Essential Experience
- 4-7 years’ experience in regulatory publishing within Pharma, CRO, CMO, or similar organisations.
- Veeva Vault configuration and administration
- Regulatory data management and lifecycle processes
- Document management systems in life sciences
- Experience in GxP-regulated environments (GMP/GDP/GVP)
- Experience working with SaaS/cloud-based platforms
- Experience with eCTD publishing tools such as MasterControl, GlobalSubmit, EXTEDO, docuBridge, PharmaREADY, or eCTDXPress also considered.
- Functional experience in Master Data Management (MDM).
- Experience with regulatory submissions across US, EU, and SFDA markets.
- Experience maintaining compliance, product lifecycle databases, and RIM systems.
- Strong cross-functional collaboration skills.
Preferred
- Experience in regulatory operations, submissions or publishing systems
- Knowledge of system validation, testing and Agile methodologies
- Veeva Vault certifications
Pay range and compensation package We offer a competitive salary plus a bonus and rewards package, including holidays, employee recognition awards, social events, a pension scheme, and hybrid working.
Equal Opportunity Statement
Pharmanovia is an equal-opportunity employer. Pharmanovia does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination.
Pharmanovia will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.
📌 RIMS Associate Manager (Veeva Vault RIMS Expert) (Mumbai)
🏢 Pharmanovia
📍 Mumbai