Job Description

Location:

Bengaluru, KA

Job Type:

Full-time

Department:

Project Management / Professional Services

Reports to:

Director of Services / Program Manager

Job Summary:

We are seeking a highly skilled and proactive

Pharmacovigilance Solutions Director

to lead the delivery and implementation of technology and process solutions across drug safety, safety signal management, quality, and regulatory compliance domains. This role will serve as a trusted advisor to our customers--ranging from large pharmaceutical firms to CROs--ensuring the successful design, configuration, and rollout of systems and services aligned with global PV standards (ICH, GVP, FDA, EMA, etc.).

Key Responsibilities:

Lead end-to-end delivery of pharmacovigilance (PV) and safety solutions including case processing, signal detection, risk management, and compliance reporting. Serve as the primary point of contact for customers on solution implementation, ensuring timelines, budget, and quality standards are met. Translate pharmacovigilance business requirements into scalable system solutions using PV platforms (e.g., Argus, ArisG, Veeva Vault Safety) or custom applications. Oversee project planning, stakeholder communication, system validation, UAT, and go-live support. Collaborate with regulatory, safety, quality, and IT stakeholders to ensure compliance with global safety standards. Ensure seamless integration of PV systems with upstream/downstream applications (e.g., EHRs, CTMS, Regulatory Systems, Quality Management Systems). Monitor evolving regulatory requirements and ensure implemented solutions are aligned with the latest standards and industry best practices. Support audits and inspections by providing documentation, evidence, and SME-level expertise on safety systems and processes. Continuously evaluate customer feedback to optimize solution delivery models and customer experience.

Qualifications:

Bachelor's or Master's degree in Life Sciences, Pharmacy, Public Health, or related field. 7+ years of experience in pharmacovigilance, with at least 3 years in a PV technology, implementation, or solutions delivery role. Strong understanding of global PV regulations (ICH E2E, GVP Modules, FDA, EMA, MHRA, PMDA). Proven experience with safety platforms (Oracle Argus, ArisG, Veeva Vault Safety, etc.). Solid project management skills with experience managing complex, cross-functional initiatives. Excellent communication and stakeholder management skills, including with regulatory and compliance teams. Experience with data analytics, signal detection, and safety compliance dashboards is a plus.

Preferred Skills:

PMP or equivalent project management certification. Experience with AI/ML-driven safety signal detection or automation in PV workflows. Knowledge of quality systems, validation, and GxP compliance frameworks.
Job Type: Full-time

Pay: ₹1,400,000.00 - ?3,200,000.00 per year

Schedule:

Monday to Friday
Supplemental Pay:

Performance bonus
Work Location: In person