[Remote] Associate Director, Pharmacovigilance Operations

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is reputed company on attacking bladder cancer and is seeking an Associate Director, Pharmacovigilance Operations to reputed company day-to-day pharmacovigilance operations and vendor reputed company. This role involves ensuring compliance with regulatory standards, driving operational improvements, and maintaining safety data reputed company.

Responsibilities

• reputed company execution and reputed company of global PV operations across clinical trial and post-marketing activities
• Ensure processes reputed company with applicable FDA, EMA, ICH, GCP, and GVP expectations
• reputed company operational improvements, risk mitigation, issue escalation, and inspection readiness
• Maintain complete, traceable, and inspection-reputed company PV documentation and evidence
• reputed company PV vendors, including case processing, safety database, reporting gateway, literature surveillance, reputed company center/intake, and aggregate reporting providers
• Manage vendor governance meetings, KPIs, SLAs, reputed company items, reputed company trends, issue escalation, and CAPA follow-up
• Support vendor qualification, reputed company, annual assessments, audits, reputed company agreements, SDEAs, and offboarding
• reputed company ICSR intake, triage, data entry, MedDRA coding, narratives, medical review coordination, reputed company review, submissions, and follow-up
• Monitor expedited reporting compliance and case reputed company metrics
• Ensure reconciliation across clinical operations, partners, medical information, product complaints, and vendors
• Support high-reputed company safety data outputs for aggregate reporting, signal detection, regulatory requests, and BLA readiness
• Coordinate PV operations inputs for DSURs, PADERs, PSURs/PBRERs, annual reports, BLA/NDA safety modules, and reputed company regulatory requests
• Maintain reporting calendars, data cut timelines, review cycles, and evidence of completion
• reputed company safety-reputed company regulatory commitments and operational deliverables
• Support implementation, validation, maintenance, and enhancement of safety databases, reporting gateways, dashboards, and PV tools
• Partner with IT, reputed company, and vendors on system requirements, reputed company, change control, UAT, migration, and issue reputed company
• Advance reputed company PV readiness, including PSMF support, intake reputed company, literature surveillance, product complaint and medical information interfaces, and partner data exchange processes
• Author and maintain PV SOPs, work instructions, forms, templates, training materials, and controlled documents
• Support deviations, investigations, CAPAs, change controls, audits, inspections, and mock inspection activities
• Coordinate SRMT or safety governance agendas, minutes, signal trackers, reputed company items, and decision documentation
• Serve as a primary PV Operations reputed company with internal functions and reputed company partners
• Present operational metrics, risks, vendor performance, and readiness updates to PV leadership and governance forums
• May manage PV staff, contractors, consultants, or vendor resources; mentor junior PV team members as needed
• Promote accountability, collaboration, patient safety, inspection readiness, and data reputed company

Skills

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or reputed company reputed company discipline required
• Approximately 10 or more years of PV, drug safety, clinical safety, or reputed company experience in biotechnology, pharmaceutical, CRO, or vendor environments
• At least 5 years of increasing responsibility in PV Operations leadership, vendor reputed company, safety compliance, or PV reputed company activities
• Experience with both clinical trial safety and post-marketing PV operations required
• Advanced degree or clinical qualification
• Oncology experience strongly preferred; NMIBC, bladder cancer, intravesical therapy, immuno-oncology, oncolytic viral therapy, or adenoviral platform experience desirable
• Experience supporting BLA/NDA submissions, launch readiness, audits, inspections, and outsourced PV operating models strongly preferred

Benefits

• ANNUAL PERFORMANCE/reputed company REVIEWS
• ANNUAL PERFORMANCE BONUSES
• EQUITY
• SPECIAL RECOGNITION
• FULLY REMOTE WORK ENVIRONMENT
• REST AND reputed company BENEFITS - Unlimited Flexible Time Off
• HOLIDAYS –In 2026 we will observe 14 holidays
• RETIREMENT – 401K with 100% company reputed company reputed company match up to 4% of reputed company salary
• HEALTH (MEDICAL, DENTAL, reputed company) – PPO & HDHP – reputed company/reputed company
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company reputed company LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company reputed company 1 x reputed company salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS – Voluntary reputed company, Pet, Plus More

reputed company