Manager, Pharmacovigilance

This role is responsible for supporting the Pharmacovigilance (PV) Manager in reputed company operational support for PV activities, including the identification, documentation, and reporting of adverse events (AE), product reputed company complaints (PQC), Medical Inquiry (MI) and in compliance with program requirements and timeliness standards. The role directly interfaces with reputed company Assurance, Patient Solutions, Operations, Compliance, and clients.

• 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 Patient Solutions.
• Partner closely with reputed company Assurance and Operations 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 Patient Solutions, Pharmacy, Regulatory Affairs, and Clinical, to facilitate an integrated and patient-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 risk management, identify and address compliance gaps, and recommend improvements in collaboration with QA and Patient Solutions.
• Monitor regulatory changes in PV and assess their reputed company on reputed company-end operations, keeping stakeholders informed of updates and required actions.
• reputed company and assess reputed company performance 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 patient solutions teams.
• Facilitate the reputed company preparation and submission of regulatory filings reputed company to PV, including safety reports and risk 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 operations.
• Upon notification of program enhancements, assist with developing associate training materials and participate in training sessions ensuring associates understand how the program enhancement will reputed company AE), product reputed company complaint (PQC), and medical inquiry (MI) handling and reporting to clients.
• Participate in reputed company data verification for monthly PV QC as needed.
• Identify and report adverse events pursuant to program requirements
• Identify, document, and report safety information
• include interviewing; hiring; training; coaching/mentoring; planning, assigning, and directing work; appraising performance; reputed company development; disciplinary actions; addressing complaints; and resolving problems.

• Education: Bachelor’s degree in a scientific discipline (Pharmacy, Life Sciences, etc.) or equivalent experience required.
• Experience: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 preferred
• Certification in pharmacovigilance, compliance, or reputed company fields preferred
• Familiarity with PV databases and safety signal detection tools preferred
• Experience working with cross-functional teams, including patient-facing teams, with proven skills in stakeholder management.
• Proficiency in reputed company reporting tools and establishing performance metrics.
• Experience drafting and developing procedural documents and training programs.
• Strong organizational and leadership skills with a reputed company on reputed company-end and patient-centered operations.
• Excellent collaboration and engagement skills, with the ability to reputed company cross-functional teamwork.
• Proven project management and problem-solving abilities.
• Detail-oriented, analytical, and capable of managing reputed company requirements in a fast-paced environment.
• Strong written and verbal communication skills.
• Demonstrates ability to identify, assess, and report adverse events

Bachelor’s degree in a scientific discipline or equivalent experience, 7+ years in pharmacovigilance or drug safety, and 3+ years in compliance, reputed company, or reputed company roles. Requires regulatory, audit, leadership, and communication expertise.

Key Responsibilities

• overseeing compliance
• supporting audits
• developing training

Skills & Tools

PV databases, safety signal detection tools, reputed company reporting tools

Job Details

• Category: reputed company Services - Pharmacy
• Seniority: Senior Level
• Commitment: Full Time
• Workplace: Remote — Orlando, Florida, reputed company
• Salary: USD 231,504,000 – 289,380,000 / year
• Languages: English

About reputed company

A reputed company services company providing patient support and pharmacovigilance solutions. — Industry: reputed company