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Pharmacovigilance Director

12-15 years
Not Disclosed
10 Nov. 27, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Pharmacovigilance Director – India (Full-Time)

Location: India
Job ID: JR 8567
Work Type: Full-Time
Company: ProPharma Group

About ProPharma

For over two decades, ProPharma has partnered with biotechnology, pharmaceutical, and medical device organisations worldwide to improve patient safety, advance scientific innovation, and accelerate product development. Through an advise-build-operate model, the company delivers comprehensive solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology.

Position Overview

The Director, Pharmacovigilance (PV) – India plays a critical leadership role in supporting the global PV strategy. This position is responsible for operational performance, compliance, team leadership, and client partnership within the Indian PV division. The Director ensures that PV operations—including adverse event processing, medical review, literature surveillance, and regulatory submissions—are conducted in alignment with global standards, SOPs, and quality benchmarks.

This role directly contributes to organizational growth, client satisfaction, and successful delivery of high-quality pharmacovigilance services.


Key Responsibilities

Strategic and Operational Leadership

  • Support long-term PV strategic objectives and ensure effective execution within the Indian PV team.

  • Oversee core PV operational activities including AE intake, SAE review, case processing, follow-up, medical review, literature surveillance, and safety migrations.

  • Maintain strict adherence to company SOPs, regulatory guidelines, and operational procedures.

  • Provide regular updates to PV Leadership and Executive Management on progress, challenges, and team performance.

Financial and Performance Management

  • Contribute to PV budgeting activities and monitor financial performance related to the Indian PV unit.

  • Evaluate productivity, efficiency, and operational KPIs and ensure alignment with financial targets.

Team Leadership and Development

  • Assess resourcing needs and support recruitment of PV personnel.

  • Provide coaching, performance feedback, and career development support to team members.

  • Conduct performance reviews, manage work allocation, and ensure operational excellence.

  • Foster collaboration across case processing and literature surveillance teams to strengthen cross-functional efficiency.

Client and Stakeholder Management

  • Support client negotiations for complex PV engagements and maintain strong governance relationships.

  • Identify opportunities to enhance client satisfaction and oversee the quality and compliance of deliverables.

  • Act as an escalation point for client concerns and ensure prompt resolution.

  • Manage transition activities following acquisitions involving the India PV team.

Operational Expertise

If required, directly support or train staff on:

  • Case intake, triage, assessment, QC, and medical review

  • Workflow state management

  • Literature search and evaluation

  • PV document management and quality investigations

  • Process improvement initiatives


Required Skills and Competencies

  • Demonstrated leadership ability with experience transitioning strategic goals into operational delivery.

  • Strong communication skills with the ability to manage complex workloads efficiently.

  • Experience working in a global, multi-stakeholder, cross-functional environment.

  • Proficiency in PV safety databases (preferably Argus).

  • Understanding of competitor service portfolios and relevant regulatory landscapes.

  • Knowledge of local legislation and market dynamics.


Experience and Qualification Requirements

Required

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

  • Minimum 12–15 years of experience in Pharmacovigilance, including significant leadership experience.

  • Demonstrated success in managing large PV teams, client relationships, and regulatory compliance activities.

  • Strong expertise in case processing operations, medical review workflows, quality oversight, and PV system management.

Preferred

  • Experience in global PV operations with multi-geography teams.

  • Broad network of contacts across PV, regulatory, or life sciences sectors.

  • Experience leading operational transformations or implementing new PV technologies.


Work Environment

ProPharma is committed to fostering a diverse, equitable, and inclusive work culture. Every application is reviewed by the in-house recruitment team, ensuring a transparent evaluation process.