At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com
Job Function:
Product Safety
Job Sub Function:
Drug & Product Safety Operations
Job Category:
Professional
All Job Posting Locations:
Bangalore, Karnataka, India, PENJERLA, Telangana, India
Job Description:
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at https://www.jnj.com/innovative-medicine
We are searching for the best talent for a Distribution Configuration Management (DCM) Analyst. This hybrid work position will be located in High Wycombe (during 2026 the office will move to Maidenhead) , United Kingdom, Bangalore or Hyderabad, India
Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).
United Kingdom - Requisition Number: R-052042
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Essential Job Duties and Responsibilities
Responsible for completing day to day operational activities in relation to the set up and maintenance of Distribution Anchors (DAs) in the Global Safety System. The DCM Analyst will also participate in collaborations with internal and external business partners to support the maintenance of the DAs to meet Regulatory reporting requirements. The Analyst will help to write and update procedural documents, be involved in continuous process improvement, metrics collection and training / mentoring of other staff in DCM. The position will also complete other relevant tasks of special assignments and provide back up to the Manager as required.
Performs Distribution Anchor (DA) related activities.
Leads interactions with Local Safety Officers to gather regulatory intelligence to support Distribution rule implementation and maintenance.
Documents local country regulatory requirements and interprets requirements into Distribution Anchors technical requirements.
Creates Distribution Anchors directly into the Global Safety system.
Manages daily workload and ensures Distribution rule related tasks are completed timely as allocated to ensure completion of daily activities.
Performs Quality Control activities of individual and team related work.
Close liaison with Distribution Configuration Management team regarding workload management. Deputizes for Manager/Director as identified.
Contributes in team meetings and performs daily liaison with team members to identify and resolve processing issues
Drives the creation and continuous improvement of consistent processes that meet both internal and regulatory standards to ensure global compliance.
Develops Metrics to monitor key performance indicators across key Distribution Configuration Management areas.
Assists Manager with implementation of processes, and issue management.
Operational Activities
Liaison with stakeholders and 3rd parties
Provide support to clarify procedures (e.g., training) to ensure compliance relating to collaboration with business partners, European Medicines Agency (EMA), Food and Drug Administration (FDA) and other Global Regulatory Authorities (RAs), Local Safety Officers (LSOs), Pharmacovigilance (PV) nominated persons, and other groups such as Global Clinical Operations (GCO), licensing partners and Regulatory Affairs (RA)
Assist with Service Level Agreements (SLAs) between GMSO and Marketing Authorization Holders (MAHs), and/or Pharmacovigilance Agreements (PVAs). In particular, the oversight of the DAs within the Global Safety system
Liaise with other functional areas to facilitate resolution of queries and issues.
Projects and Initiatives
Acts as Subject Matter Expert (SME) when requested in one or more of the below activities:
Regulatory Reporting intelligence
Quality monitoring activities
Process/system improvement
Compliance and quality metrics preparation
Controlled document creation/update
Quality Investigations and CAPA activities
Identifies and develops solutions for areas needing improvement and considers the use of technology for the automation of process steps.
Quality and Compliance
Develops / updates Standard Operating Procedures (SOPs) and other controlled documents relevant for the coordination of tasks, business continuity and audit/inspection readiness.
Represents Distribution Configuration Management in audits and inspections when requested and provides support for document requests.
Investigate, document and track compliance related data and identify any trends.
Other
Minimum Qualification
Education:
Required Experience
Developed Understanding of US and EU electronic regulatory reporting requirements for ICSRs.
Accumulated expertise in pharmacovigilance operations related activities including single case processing, database queries, expedited reporting.
Knowledge of regional and global safety regulations
Good understanding of technologies, systems and databases related to E2B electronic reporting.
Highly reliable, and compliant with legal and company guidelines
Excellent organizational and communication skills including presentation abilities.
Ability to produce high quality work under time critical and high-pressure situations.
Project Management Skills desirable
Required Skills:
Preferred Skills:
