Job Title: Digital Science Functional Expert – Pharmacovigilance
Company: Opella
Location: Hyderabad, India
Job Type: Full-Time
Experience Required: 3–5 Years
Qualification: Bachelor's or Master's Degree in Business, Information Systems, Life Sciences, Pharmacy, Computer Science, or related field
About the Role
Opella is looking for a Digital Science Functional Expert – Pharmacovigilance to support and enhance global pharmacovigilance digital platforms. The role combines Pharmacovigilance domain expertise with Business Analysis, Product Ownership, Digital Transformation, and Pharmacovigilance Systems Management. The candidate will act as a bridge between PV business teams, IT teams, vendors, and regulatory stakeholders to ensure compliant, efficient, and innovative pharmacovigilance operations globally.
Key Responsibilities
Product Backlog & Agile Delivery
Manage and maintain product backlogs for Pharmacovigilance platforms.
Translate business requirements into user stories, epics, and acceptance criteria.
Develop functional specifications and support Agile delivery processes.
Track project progress and proactively identify risks and blockers.
Support issue resolution and functional troubleshooting activities.
Pharmacovigilance Systems Management
Support end-to-end pharmacovigilance operations within Aris Global platforms.
Manage systems supporting ICSR processing, signal management, aggregate reporting, and regulatory submissions.
Support configuration and lifecycle management of LSMV, Navax, Signal Management, and related PV applications.
Ensure compliance with global pharmacovigilance and regulatory requirements.
Support MedDRA coding, E2B submissions, case processing, and safety reporting workflows.
Validation & Compliance
Participate in Computer System Validation (CSV) and GxP validation activities.
Support User Acceptance Testing (UAT) and release validation processes.
Ensure compliance with:
ICH E2B(R3)
GVP Guidelines
FDA Regulations
EMA Requirements
21 CFR Part 11
Maintain inspection and audit readiness across PV systems.
Vendor & Stakeholder Management
Coordinate with Aris Global and other digital solution vendors.
Monitor support ticket SLAs and issue resolution timelines.
Escalate recurring issues and drive continuous improvement initiatives.
Collaborate with global pharmacovigilance teams and business stakeholders.
Gather user feedback and support prioritization of enhancement requests.
Product Governance & Documentation
Support product governance activities and roadmap execution.
Develop and maintain SOPs, release notes, training materials, and user guides.
Monitor system adoption, performance metrics, and user engagement.
Drive change management and training initiatives for PV users globally.
Required Skills
Pharmacovigilance Operations
Drug Safety Systems
Aris Global LSMV
Signal Management
ICSR Processing
MedDRA Coding
E2B(R3) Submissions
Business Analysis
Product Ownership
Agile Methodology
User Story Writing
Functional Requirement Gathering
UAT & Validation
Regulatory Compliance
Vendor Management
Stakeholder Management
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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