Master Data Analyst

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The Position

Are you excited about Data? Do you believe that data can make the organisation become more successful and efficient in achieving its goals? Do you want to take charge and drive new and exciting data related initiatives and adoption of good data culture? Then your place is with us!

We are the Data & Analytics Chapter, part of Integrated Informatics at Roche. We build excellence and mastery in next generation data and analytics capabilities, including but not limited to Data Science, Data Engineering, Analytics and Data Management & Governance.  We release value from data - all the way from Discovery to Insights.

In addition to partnering with teams across the business to develop solutions, scale and automate data pipelines, Data & Analytics Chapter members are uniquely placed to connect the dots across initiatives, promote information sharing across domains and recommend re-use of data, analytics and solutions wherever possible.

The Position

• As the Master Data Analyst for Pharmacovigilance Information and Systems (PVIS) you will be a key member of the Data Management & Governance section within the Data & Analytics chapter.

• The primary responsibility of the Master data analyst is to deliver IT operation services that enable our business partners to reliably deliver value of safety to advance products that patients need next

• You will report to the Section Lead and work very closely with the global PVIS team located in SSF, Basel and Welwyn (UK).

• You are located in Kuala Lumpur and focus of this position is on the master data operation support and administration of systems for which PVIS has business system ownership

• The PVIS group has overall responsibilities for business owned safety systems activities, in particular enabling the exchange of individual case safety reports according to international and local reporting requirements, to Drug Safety Affiliates, health authorities and licensing partners

Academic Requirement

Bachelor's degree in Information Technology, or a related Information Engineering or Sciences discipline (or equivalent experience). 

Key competencies

• Passionate about learning, sharing and further developing “best practice” and embed it as “next practice” to achieve greater impact

• Agile competencies: having a growth mindset, knowing yourself, being courageous and get connected

• Meticulous and able to handle data is a must

• Good communication skills

• Strong attention to detail

• Strong analytical skills

• Good in documentation

• Good team player

• High customer orientation.

• Demonstrated strong sense of urgency (highly regulated domain)

Key responsibilities

Master data Analyst plays multiple roles, with each role having specific responsibilities as stated below:

Adverse Event Report Submission Alert (ASA) Monitoring 

• Adverse event reporting is a regulatory requirement in most countries for pharmaceutical companies. It provides critical data to both companies and regulatory authorities, playing a vital role in assessing the risk-benefit profile of a drug. ASA ensures timely and successful submission of adverse event information to safeguard patient safety. It continuously monitors patient safety and reduces risks throughout the product life cycle.

• Scope of ASA includes:  

  • Monitoring adverse event submissions for failed acknowledgments and distributions, including overseeing, analysing, and resolving submission-related issues.

  • Addressing submission issues and queries.

  • Supporting Corrective Action Preventive Action (CAPA) and compliance investigation activities.

  • Fully managing adverse event submission failures, ensuring operational performance, and acting as the primary contact for stakeholders in the Pharmacovigilance (PV) department.

  • Contributing to operational strategy and participating in the development and implementation of new processes and systems aimed at improving quality and efficiency.

  • Providing updates to stakeholders on submission failures and regulatory changes, as well as creating and updating Standard Operating Procedures (SOPs) and work instructions.

  • Ensuring that PV processes, procedures, and systems comply with Roche Global PV procedures and local/regional PV regulations.

  • Aligning affiliate PV system procedures with corporate PV procedures to ensure compliance with local and regional PV regulations.

Master Data Management

• You are responsible to track and manage PVIS (PV Intelligent Automation & Business Systems Solutions) master data and business configuration. This includes:

  • User accounts management, product dictionaries, regulatory rules, document templates, etc.

  • Act as a process owner for Master Data activities and work closely with the management team to ensure that the process remains effective and works efficiently.

Domain Expert

• Maintain a good understanding of business processes and context in which the IT services are consumed within the Drug Safety or any others regulated industries 

• Apply knowledge of systems, tools and problem solving skills in the respective domain.

• Continual self-development to maintain up-to-date knowledge of the industry and domain of specialisation.

Technical Expert

• Apply hands-on skills in the underlying technologies required to operate, maintain and enhance the solutions.

Qualifications

• You have 1-3 years of Data Analytics / Master Data experience

• You have 1-3 years of experience in supporting highly regulated applications, preferably within the Pharma business domain and technology, and have proficient knowledge of pharmaceutical technology and processes. 

• Knowledge of drug safety regulatory obligations and guidelines or other relevant experience in the drug development environment within the pharmaceutical industry is an added advantage.

• You have experience in working in a regulated environment and with Computer System Validation. Working knowledge of industry standard safety systems.

• Demonstrates a strong commitment to adhering to relevant regulations and procedures, with a focus on meeting regulatory deadlines

• Pharmacovigilance (or safety monitoring/reporting) experiences preferred but not mandatory

• Experienced in IT Service Management is highly preferable

• You are able to communicate fluently and effectively in English (written and spoken).

• ITIL certification is an advantage

Working hours

Ability to support Drug Safety Operations during public holidays, with core working hours from 7am to 4pm and flexibility to extend support from 10am to 7pm when needed. Standard working hours apply, with additional flexibility to attend virtual meetings outside of regular hours.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

The Roche Services & Solutions as well as People Support Solutions organisations located in Kuala Lumpur provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the APAC region. Today Roche employs altogether around 1100 employees in Malaysia.

Roche is an Equal Opportunity Employer.