Job Title
Senior Specialist, BT Pharmacovigilance
Job Details
Company: Organon
Location: Mumbai, India
Job Type: Full Time | Regular
Requisition ID: R536929
Experience Required: 8–10 years
Education Required: Bachelor’s degree (Engineering / Sciences / Information Systems or related field)
Work Arrangement: Hybrid
Relocation: Not applicable
Visa Sponsorship: Not available
Travel Requirement: Up to 10%
Openings: 1
Position Overview
The Senior Specialist, BT Pharmacovigilance will report directly to the Director of Pharmacovigilance Business Technology and play a vital role as part of the R&D Business Technology Services team.
The position focuses on supporting, maintaining, and enhancing Pharmacovigilance (PV) systems through business and technical analysis, ensuring compliance, and optimizing global drug safety operations.
The ideal candidate will have a strong understanding of both Pharmacovigilance processes and Business Technology Services (BTS) methodologies such as Change Management, Service Management, SDLC, and Incident Management.
Key Responsibilities
Provide top-tier support for Global Safety systems.
Manage day-to-day operations and support activities for Global Safety platforms.
Serve as the functional owner for key PV systems:
PV Reporting (PV Reports)
Case Management (Argus Safety)
Related safety systems
Establish and monitor performance metrics for platform operations.
Ensure regulatory compliance and proper documentation through:
Requirements gathering and documentation
User Acceptance Testing (UAT) planning and coordination
Requirements traceability and SDLC adherence
Collaborate with business and technology stakeholders to design and implement new solutions or updates.
Partner with vendors, business clients, and service management teams to ensure efficient system support and enhancements.
Required Qualifications & Experience
Bachelor’s degree in Engineering, Sciences, Information Systems, or related discipline (or equivalent).
8–10 years of relevant experience in:
Business analysis
Pharmacovigilance / Drug Safety solutions
Supporting Global Safety Applications such as Argus Safety, PV Reports, PV Signals
Proven experience managing multiple tasks and priorities in a complex work environment.
Strong knowledge of Compliance, Computer System Validation (CSV), and Data Integrity.
Proficiency in creating:
User stories and requirements
Process flows and data mappings
Use cases and wireframes
Analytical and problem-solving mindset with creative thinking.
Excellent communication and interpersonal skills for cross-functional collaboration.
Experience in SDLC documentation and IT project delivery.
Preferred Qualifications
Experience working in Agile development environments.
Domain expertise in Pharmacovigilance and Drug Safety systems.
Key Competencies
Collaboration and stakeholder management
Business analysis and documentation
Regulatory and compliance understanding
PV system administration and validation
Problem-solving and critical thinking
About Organon
Organon is a global healthcare company with annual revenues exceeding $6.5 billion, dedicated to delivering innovative health solutions that enable people to live their best lives.
The company focuses on:
Women’s Health
Biosimilars
Established medicines
Organon’s vision is:
“A better and healthier every day for every woman.”
Organon fosters a diverse, inclusive, and collaborative workplace where all employees are empowered to make a difference.
Additional Information
Employee Status: Regular
Work Mode: Hybrid
Travel: 10% (subject to credentialing and vaccination requirements)
Relocation Assistance: Not available
Visa Sponsorship: Not available
Valid Driving License: Not required
Hazardous Material Handling: Not applicable
Equal Opportunity Statement
Organon is an equal opportunity employer, welcoming candidates from all backgrounds and fostering an inclusive environment.
Search firms are advised not to send unsolicited resumes, as Organon does not accept agency referrals without a valid written agreement.
✅ Apply Now: Organon Careers (add correct link if available)
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