Job Description

Job Title: Safety Report Design & Development Specialist

???? Location: India
???? Job Type: Permanent

???? Main Responsibilities

• Lead and participate in the design, development, and deployment of safety reports.

• Support digital vendor teams with safety report compliance, development, testing, and deployment.

• Integrate data from multiple sources across the enterprise for effective safety reporting.

• Maintain validation of safety reports generated from LSRA.

• Plan and prioritize report deployment based on business needs.

• Support QPPV office with oversight reports.

• Manage incidents and changes for LSRA, LSSRM, and PSUR webpage tools.

• Collaborate with PV country and global teams during audits and inspections to provide ad-hoc and urgent safety reports.

• Gather and document reporting requirements in discussions with business stakeholders.

• Maintain existing reports periodically and during system upgrades.

• Collaborate with vendors and assist during transition periods, incidents, and escalations.

• Actively support evolving drug safety regulations.

• Operate within an Agile work environment.

???? About You

Experience:

• 6–8 years in the pharmaceutical industry, specifically within GxP systems and pharmacovigilance.

• Hands-on experience with PV databases: ARGUS, Aris-G (LSMV), Cognos.

• Expertise in PV reporting systems operations as a business analyst, configuration manager, or relationship manager.

• Programming knowledge: Python, R.

• Database: SQL, PL/SQL; Power BI with DAX.

• Development exposure to AI/ML, LLM, NLP is preferred.

• In-depth understanding of pharmacovigilance processes, regulations (ICH GCP, GxP).

• Skilled in validation processes and system documentation.

• Familiar with safety reporting requirements (CIOMS, EudraVigilance, FDA REMS).

Technical Skills:

• Database Management: Proficiency in safety systems (e.g., Aris-G / LSMV, Argus, VigiBase).

• Business Intelligence: Power BI or Spotfire for dashboards and visual reporting.

• Software Testing/Validation: Knowledge of UAT and data migration.

• Microsoft Office Suite: Advanced Excel, Word, PowerPoint.

• Presentation & Communication: Ability to present findings clearly and concisely.

• Cross-functional Collaboration: Work effectively with clinical, regulatory, medical affairs teams.

Soft Skills:

• Strong stakeholder management, negotiation, and communication abilities.

• Strategic thinking, project leadership, and multitasking across functions.

• Analytical mindset with problem-solving skills and attention to detail.

• Experience managing global operations and large multi-country budgets.

• Excellent team collaboration and multicultural adaptability.

???? Education:

• Bachelor’s degree in Pharmacy, Life Sciences, Engineering, or related field.

???? Language:

• Fluent in English (verbal and written)

This role offers an exciting opportunity to be at the forefront of pharmacovigilance operations, contributing strategically to safety reporting and regulatory compliance across a global platform.

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