Pharmacovigilance Manager

at  Dynasty clinic

The Pharmacovigilance Manager oversees all pharmacovigilance (PV) activities to ensure compliance with regulatory requirements and organizational standards. This role involves managing safety data collection, assessment, reporting, and ensuring the safe use of pharmaceutical products.

Key Responsibilities:1. Strategic Planning and Management:

• Develop and implement pharmacovigilance strategies and processes in compliance with local and international regulations (e.g., FDA, EMA, WHO).
• Ensure compliance with Good Pharmacovigilance Practices (GVP) and company policies.

1. Safety Data Collection and Reporting:

• Oversee the collection, management, and analysis of adverse event reports.
• Ensure timely submission of safety reports, including Individual Case Safety Reports (ICSRs) and Periodic Safety Update Reports (PSURs) to regulatory authorities.

1. Risk Management:

• Develop and maintain Risk Management Plans (RMPs) for products.
• Monitor and assess signal detection activities to identify potential risks.

1. Regulatory Compliance:

• Ensure alignment with global pharmacovigilance regulations and standards.
• Respond to regulatory authority inquiries and audits.

1. Team Leadership and Training:

• Manage and mentor the pharmacovigilance team, ensuring consistent training on PV policies and updates.
• Collaborate with cross-functional teams, including R&D, regulatory affairs, and quality assurance.

1. Database and System Management:

• Oversee the maintenance of the PV database and ensure its functionality for safety data collection and analysis.
• Ensure data privacy and compliance with applicable regulations.

1. Stakeholder Communication:

• Act as the main point of contact for internal and external stakeholders regarding safety concerns.
• Prepare and present safety data to senior management, regulatory authorities, and business partners.

1. Continuous Improvement:

• Identify areas for process optimization within pharmacovigilance operations.
• Stay updated on industry trends, new regulations, and best practices.

Job Type: Full-tim

• Develop and implement pharmacovigilance strategies and processes in compliance with local and international regulations (e.g., FDA, EMA, WHO).
• Ensure compliance with Good Pharmacovigilance Practices (GVP) and company policies