Responsable Pharmacovigilance - Pharmacovigilance Manager - CDI

Handling of adverse events, medical inquiries and product quality complaints reported with the company products;

Coordinating with the case processing team for the timely processing and submission of IC

Coordinating with the quality team for the timely evaluation of product quality complaints and provide response to reporters;

Coordinating with the Responsible Pharmacist and provide appropriate response to medical inquiries;

Responsible to author PSURs and RMPs;

Responsible to coordinate with signal management team for the potential signals identified and its monitoring;

Responsible to ensure compliance of all pharmacovigilance activities like case processing, medical writing, signal detection etc.,;

Responsible for creating, monitor, follow-up and closure of deviations, CAPA;

Responsible to create and maintain SOPs in compliance with regulatory expectations;

Responsible for document management in collaboration with quality department;

Ensuring a full and prompt response to any request from the competent authorities in Members States and from the Agency for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product;

Providing any other information relevant to the benefit-risk evaluation to the competent authorities in Members States and the Agency;

Providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals);

Responsible to implement necessary measures and comply with the GDPR expectations;

Bachelor/Master of Pharmacy/Medicine

Minimum 5 years’ experience in handling Pharmacovigilance activities like case processing, PSURs, Risk Management Plans, Signal Management, etc.,

Handling of regulatory audits, QMS.