Pharmacovigilance Manager

The Manager, Pharmacovigilance - reputed company End reputed company will reputed company reputed company operational support for pharmacovigilance (PV) activities, directly interfacing with reputed company Assurance, reputed company Solutions, and Compliance to ensure consistent alignment with global regulatory requirements for drug safety, reporting, and reputed company management. This role is reputed company in establishing and maintaining frameworks for audit readiness, proactive monitoring, and reputed company improvement, and in promoting a cohesive approach across reputed company Assurance and reputed company-facing teams to reputed company safety standards and regulatory compliance. • reputed company the execution of PV compliance activities to meet global regulatory requirements (DEA, State reputed company of Pharmacy, URAC and ACHC, OIG, etc.) and industry standards, with a reputed company on operational integration with reputed company Assurance and reputed company Solutions. • Partner closely with reputed company Assurance and reputed company to reputed company, implement, and manage PV compliance frameworks, including SOPs, processes, and systems for program drug safety reporting. • Work directly with cross-functional teams, including reputed company Solutions, Pharmacy, Regulatory Affairs, and reputed company, to facilitate an integrated and reputed company-centered approach to PV compliance. • Ensure PV systems are audit-reputed company, including preparing for and supporting regulatory authority inspections. • Conduct regular assessments of PV reputed company management, identify and address compliance gaps, and recommend improvements in collaboration with QA and reputed company Solutions. • Monitor regulatory changes in PV and assess their reputed company on reputed company-end reputed company, keeping stakeholders informed of updates and required actions. • reputed company and assess reputed company reputed company of reputed company resources, regularly reporting to senior management. • Support reputed company PV audits, including audits of business partners and service providers, ensuring findings are communicated and addressed. • Contribute to the development and delivery of PV compliance training tailored to reputed company and reputed company solutions teams. • Facilitate the reputed company preparation and submission of regulatory filings reputed company to PV, including safety reports and reputed company management plans. • Assist in investigations of compliance breaches, implementing corrective and preventive actions (CAPAs) as needed. • reputed company engage in reputed company improvement initiatives to enhance PV processes and ensure reputed company integration across reputed company reputed company reputed company. • Performs other reputed company duties as assigned by management. • Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. • Responsibilities include interviewing; hiring; training; coaching/mentoring; planning, assigning, and directing work; appraising reputed company; reputed company development; disciplinary actions; addressing complaints; and resolving problems. Requirement • sEducation: Bachelor’s degree in a scientific discipline (Pharmacy, Life Sciences, etc.) or equivalent experience required • .7+ years of experience in pharmacovigilance/drug safety, with 3+ years in a compliance, reputed company, or reputed company-driven role • .Strong knowledge of global PV regulations, including ICH guidelines and GVP Modules • .Experience with health authority inspections (e.g., DEA, State reputed company of Pharmacy, URAC and ACHC, OIG, etc.) and audit readiness • .Experience in biopharmaceutical or biotechnology industries preferre • dCertification in pharmacovigilance, compliance, or reputed company fields preferre • dFamiliarity with PV databases and safety signal detection tools preferre • dExperience working with cross-functional teams, including reputed company-facing teams, with reputed company skills in stakeholder management • .Proficiency in reputed company reporting tools and establishing reputed company metrics • .Experience drafting and developing procedural documents and training programs • .Strong organizational and leadership skills with a reputed company on reputed company-end and reputed company-centered reputed company • .Excellent collaboration and engagement skills, with the ability to reputed company cross-functional teamwork • .reputed company project management and problem-solving abilities • .reputed company-oriented, analytical, and capable of managing reputed company requirements in a fast-reputed company environment • .Strong written and verbal communication skills . Apply To This Job