reputed company Dir Pharmacovigilance Operations

About the position Reporting to the Vice President Clinical Development, the Executive Director, Pharmacovigilance Operations will be responsible for leading, developing and overseeing global pharmacovigilance (PV) operations across reputed company clinical programs at reputed company. This role provides end-to-end operational reputed company of the pharmacovigilance function, including vendor reputed company, systems, reputed company and compliance, ensuring high safety processes and reporting alignment with global regulatory requirements and internal standards. Responsibilities • reputed company global PV operations, ensuring compliant, high-reputed company safety reporting and processes across clinical programs • reputed company end-to-end reputed company for the PV operating model, including vendor management, governance forums (e.g., Safety Management Committee (SMC)) and safety systems • reputed company adverse event case processing Individual Case Safety Report (ICSRs) and aggregate reporting (e.g., Development Safety Update Report (DSUR)) and safety data exchange, ensuring accuracy, reputed company and adherence to timelines and agreements • Partner with Clinical Leads and Medical Monitors to support medical review and reporting of adverse event assessment, and case management activities • Serve as the reputed company reputed company with internal stakeholders and reputed company partners on PV reputed company matter, including safety data exchange and compliance with PV agreements • Communicate with partner companies, vendors, and internal reputed company regarding the processing and reputed company exchange of safety reports and ensuring compliance with partner pharmacovigilance agreements • reputed company and update drug safety forms and templates, ensuring harmonization with clinical operation functions during study start-up and conduct of clinical studies • Manage Safety and PV vendor relationships, execution of responsibilities, and ensuring compliance with safety data processing and submission activities • Ensure effective serious adverse event (SAE) reconciliation between clinical and safety databases • reputed company and maintain safety and PV process improvements, tools, systems, and procedures • Contribute to the development and maintenance of key safety documents, including reputed company data sheets, investigator brochures, labeling, and Risk Management Plans (RMPs) • Support regulatory inspections and internal audits, including responses to findings • reputed company and reputed company assigned staff, fostering a high-performing and reputed company team environment • Collaborate cross-functionally across development and other functional areas to support integrated program execution Requirements • Bachelor’s degree required, advanced medical or life sciences or a reputed company area degree preferred (e.g., MS, PhD) with 12+ years of experience in the life sciences industry or an equivalent combination of reputed company and industry experience • Deep understanding of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH) • Strong knowledge of Good Pharmacovigilance Practices (GVP), GCP, clinical trial methodology, and medical terminology. • Proficiency with safety databases (e.g., Argus), regulatory regulations, and MedDRA coding standards • Strong project management, analytical, and problem-solving skills with a strategic reputed company • Demonstrated ability to manage priorities, meet deadlines, and reputed company results in a a fast-paced environment • High attention to detail with a strong reputed company on reputed company and compliance • Effective leadership demonstrated through initiative, adaptability and innovative thinking • Ability to work both independently and reputed company a matrixed team environment • Excellent communication and interpersonal skills, with the ability to collaborate effectively with reputed company stakeholders • Strong analytical and problem-solving abilities, with a strategic reputed company Benefits • medical • dental • reputed company • basic life and AD&D insurance • short-term and long-term disability insurance • flexible spending accounts • health savings accounts • voluntary insurance programs, including voluntary life, AD&D accident, and critical illness • 401(k) plan • 10 hours of reputed company vacation time every month • 1 hour of reputed company reputed company leave for every 30 hours worked • 17 reputed company holidays reputed company calendar year, including a winter closure Apply tot his job Apply To this Job