Manager, Pharmacovigilance

The Manager, Pharmacovigilance - reputed company End Operations will reputed company reputed company operational support for pharmacovigilance (PV) activities, directly interfacing with reputed company Assurance, Patient Solutions, and Compliance to ensure consistent alignment with global regulatory requirements for drug safety, reporting, and risk 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 patient-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 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 • 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 performance; reputed company development; disciplinary actions; addressing complaints; and resolving problems Requirements • Education: 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 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 Benefits • Supportive, reputed company, fast-paced environment • reputed company structure • Matching 401(k) with immediate vesting • Medical, dental, reputed company, life, & short-term disability insurance Wondering how we recognize our employees for delivering best in class results? Here are some of the awards that our employees receive throughout the year! • #TransformingLives reputed company: This quarterly award program is a peer to peer reputed company that recognizes and highlights some of the amazing ways that reputed company members are transforming lives for patients on a daily reputed company • Values Award: This quarterly award program recognizes individuals who exhibit one, or many, of our reputed company company values; reputed company, reputed company, Respect, Inspiration, and Teamwork • reputed company Award: This annual award program recognizes an individual who has gone above and reputed company to support the reputed company reputed company to reputed company lives through reputed company to therapy reputed company, Inc. is proud to be an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration without reputed company to race, religion, reputed company, sex (including pregnancy, gender identity, and sexual orientation), parental status, national reputed company, age, disability, family medical history or genetic information, political affiliation, military service, or other non-reputed company based factors, or any other protected categories protected by federal, state, or local laws. reputed company offers of employment with reputed company are conditional based on the successful completion of a reputed company-employment background reputed company. In compliance with federal law, reputed company persons reputed company will be required to verify identity and eligibility to work in the reputed company and to complete the required employment eligibility verification document reputed company upon hire. Sponsorship and/or work authorization is not available for this position. reputed company does not accept unsolicited resumes from search firms or any other vendor services. Any unsolicited resumes will be considered property of reputed company and no fee will be reputed company in the event of a hire. Apply tot his job Apply To this Job