Associate Director / Director – Pharmacovigilance Services
Company: Novotech
Location: India
About the Role
The Director, Pharmacovigilance Services is a senior leadership role responsible for leading the pharmacovigilance (PV) function across clinical and post-marketing projects.
This role ensures delivery of high-quality PV services while meeting financial, operational, regulatory, and client satisfaction targets. The position also plays a key role in business development, audit readiness, and global regulatory compliance.
You will collaborate across:
Operations
Finance
IT
Business Development
External vendors and clients
Key Responsibilities
1. Leadership & Team Management
Lead, mentor, and manage pharmacovigilance teams.
Conduct hiring, onboarding, training, and performance management.
Assign workloads and ensure effective resource planning.
Support professional development and performance improvement plans.
Ensure staff compliance with SOPs and regulatory requirements.
2. Pharmacovigilance Operations Oversight
Oversee PV activities for clinical trials and post-marketing surveillance.
Ensure compliance with:
ICH GCP
ICH E2B (R3)
Global safety regulations
Ensure inspection and audit readiness at all times.
Monitor quality of PV deliverables and operational performance.
3. Quality, Compliance & Regulatory Governance
Ensure adherence to global PV standards and company SOPs.
Evaluate processes for compliance with regulatory expectations.
Maintain up-to-date PV documentation and policies.
Ensure corrective and preventive actions (CAPA) are implemented.
4. Financial & Business Management
Manage PV budgets, pricing, and financial performance.
Ensure projects are delivered within scope, timeline, and budget.
Review proposals and support commercial decision-making.
Contribute to business development and client acquisition.
5. Client & Stakeholder Management
Represent the organization to clients and external partners.
Ensure strong client satisfaction and relationship management.
Collaborate with business development teams for new opportunities.
Provide functional input to strategic business decisions.
6. Training & Capability Development
Identify training needs across PV teams.
Work with HR and L&D teams to design learning programs.
Ensure onboarding and continuous development programs are effective.
7. Audit & Inspection Readiness
Ensure PV systems and teams are inspection-ready.
Support regulatory audits and client inspections.
Ensure compliance documentation is maintained and updated.
8. Process Improvement & Strategy
Evaluate and improve PV processes and workflows.
Ensure alignment with global regulatory standards.
Drive operational efficiency and innovation.
Contribute to strategic growth of PV services.
Educational Qualifications
Registered Nurse OR Pharmacist OR Biomedical/Health Sciences degree (mandatory)
Postgraduate qualification or clinical trials certification (preferred)
Experience Requirements
Strong experience in:
Pharmacovigilance (clinical trials and/or post-marketing)
Global safety regulations
Team leadership and operational management
Experience in:
PV safety databases
MedDRA coding
WHO-DD coding
ICH guidelines compliance
Required Skills & Competencies
Leadership Skills
Strong ability to lead, mentor, and manage teams.
Performance management and conflict resolution skills.
Ability to build high-performing teams.
Technical PV Knowledge
Deep understanding of pharmacovigilance systems and workflows.
Knowledge of:
ICH GCP
E2B R3
Global drug safety regulations
Experience with safety databases and coding systems.
Financial & Strategic Skills
Budget planning and financial management.
Contract and pricing understanding.
Ability to align operations with business strategy.
Communication & Stakeholder Skills
Strong verbal and written communication skills.
Client-facing leadership capability.
Ability to influence cross-functional teams.
Operational Skills
Ability to manage multiple complex projects.
Strong attention to detail and regulatory compliance mindset.
Ability to work in fast-paced global environments.
Personal Attributes
Strong leadership presence.
Strategic and analytical thinking.
High accountability and ownership.
Adaptability and decision-making ability.
Strong ethical and compliance mindset.
Summary
This is a senior leadership role in Pharmacovigilance, responsible for:
Team leadership
Regulatory compliance
Financial performance
Client management
Global PV operations
Business growth
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Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Remote, India | Siliguri |Illinois :
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