DCM Analyst

Job Summary Distribution Configuration Management (DCM) Analyst – responsible for the setup and maintenance of Distribution Anchors (DAs) in the Global Safety System, collaborating with internal and external partners and ensuring regulatory compliance. Key Responsibilities Complete day-to-day operational activities related to the setup and maintenance of DAs in the Global Safety System. Collaborate with Local Safety Officers to gather regulatory intelligence and implement Distribution rule changes.

Document local country regulatory requirements and translate them into technical requirements for DAs. Create and maintain DAs directly in the Global Safety System. Manage daily workload, ensuring timely completion of Distribution rule‑related tasks and quality control activities.

Perform informal testing of new or modified DAs and provide quality‑control reviews of team work. Lead interactions with business partners, EMA, FDA, other Global Regulatory Authorities, LSOs, PV nominated persons, Global Clinical Operations and licensing partners. Support training and mentoring of other staff in DCM.

Assist in the development and continuous improvement of processes to meet internal and regulatory standards. Develop and monitor key performance metrics in DCM activities. Act as Deputy for the Manager/Director and support the Manager in issue management and process implementation.

Provide backup, inform and resolve issues, including impact assessments and bolus management. Contribute to subject‑matter‑expert activities, including regulatory reporting intelligence, quality monitoring, process/system improvement and CAPA activities. Maintain knowledge of worldwide regulations and guidance for ICSR case processing.

Qualifications Education : Degree in life sciences, Pharmacy, or related field; advanced degree preferred. Experience : Understanding of US and EU electronic regulatory reporting requirements for ICSR; expertise in pharmacovigilance operations (single case processing, database queries, expedited reporting). Skills : Knowledge of regional and global safety regulations; familiarity with E2B electronic reporting technologies and databases; excellent organizational, communication, and presentation skills.

Ability to work under time‑critical and high‑pressure situations and produce high‑quality work. Project‑management skills desirable. Additional preferred skills and experience may include regulatory reporting, quality monitoring, process improvement and CAPA.

Locations High Wycombe (UK), Raritan (NJ), Titusville (NJ), Horsham (PA), Bangalore or Hyderabad (India). Position may relocate to Maidenhead (UK) in 2026. Compensation & Benefits Base pay range: $92,000.00 – $148,350.00.

Eligibility to participate in the company’s consolidated retirement plan (pension) and savings plan (401(k)). Long‑term incentive program. Vacation – 120 hours per calendar year.

Sick time – 40 hours per calendar year (48 hours in Colorado, 56 hours in Washington). Holiday pay – 13 days per calendar year. Work, Personal and Family Time – up to 40 hours per calendar year.

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child. Bereavement Leave – 240 hours (40 for an extended family member per calendar year). Caregiver Leave – 80 hours in a 52‑week rolling period.

Volunteer Leave – 32 hours per calendar year. Military Spouse Time‑Off – 80 hours per calendar year. #J-18808-Ljbffr