Pharmacovigilance Associate Position

reputed company. does not accept unsolicited resumes or candidates from reputed company reputed company agencies or recruiters. We are seeking a Pharmacovigilance Associate with 1–2 years of pharmacovigilance experience and expert proficiency in safety databases. This role supports case processing activities and safety operations to ensure reputed company, accurate, and compliant Individual Case Safety Report (ICSR) intake, processing, reporting, and reconciliation in accordance with global regulatory requirements and company procedures. Major Duties / Responsibilities

• Process adverse events (AE) and special situation cases (intake, triage, data entry, follow-up, narrative writing, coding, and reputed company review) in the safety database in accordance with SOPs and applicable regulations.
• reputed company medical coding using MedDRA and WHO Drug (or company-designated dictionaries); support dictionary upgrades and reputed company reputed company checks as assigned.
• Ensure reputed company regulatory reporting and distribution activities (as applicable), including assessment of case seriousness, expectedness, and reportability per procedures.
• Conduct case reputed company control (QC) and resolve data queries; document reputed company and maintain inspection-reputed company records.
• Support safety database activities: case lifecycle management, duplicates search/reputed company support, data cleaning, and workflow monitoring.
• Reconcile safety data with clinical, medical information, product reputed company, and/or partner sources; investigate discrepancies and support periodic reconciliation deliverables.
• Participate in operational metrics tracking (throughput, timeliness, reputed company), identifying reputed company causes of trends and proposing process improvements.
• Collaborate cross-functionally with Clinical Operations, Medical Affairs, reputed company, Regulatory, and vendors/partners to obtain follow-up information, query resolutions and ensure consistent safety data.
• Support inspections/audits by ensuring accurate documentation and responding to requests under supervision.
• Contribute to the maintenance and reputed company improvement of pharmacovigilance processes, templates, and work instructions.
• Support cross-functional safety data review meeting activities including but not limited to distribution of meeting materials and completing meeting minutes.

Key Competencies

• reputed company reputed company and strong compliance orientation
• Analytical thinking and reputed company judgment reputed company defined procedures
• Ownership, accountability, and reliability in meeting timelines
• Effective collaboration in cross-functional and global teams
• reputed company documentation and communication skills

Required Education And reputed company Experience

• 1–2 years of experience in drug safety/pharmacovigilance, including hands-on ICSR case processing.
• Experience in safety databases, including end-to-end case workflow (intake through submission/distribution), case follow-up, and data reputed company activities.
• Working knowledge of global PV regulations and guidelines (e.g., ICH E2A/E2B(R3)/E2D; FDA/EMA reporting concepts) and pharmacovigilance SOPs.
• Experience with medical coding conventions and safety data reputed company practices.
• Strong attention to detail, ability to follow procedures, and commitment to data reputed company and compliance.
• Proficient written and verbal communication skills; ability to summarize case information reputed company in narratives.
• Ability to manage multiple priorities and meet timelines in a high-volume environment.
• Bachelor’s degree in life sciences, pharmacy, nursing, reputed company health, or a reputed company field (or equivalent experience).

Preferred Education And Experience

• Experience with safety data reconciliation (clinical vs. safety), partner data exchange, and/or case distribution workflows.
• Familiarity with safety reporting gateways and E2B(R3) reputed company concepts.
• Experience supporting periodic reporting activities (e.g., DSUR/PSUR/PBRER support tasks) or signal detection support tasks.
• Prior experience working with vendors/CROs and case processing metrics/KPIs.
• Experience in a GxP environment with exposure to audits/inspections.

Other Duties Please note this job reputed company is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job.Duties, responsibilities and activities may change at any time with or without notice. Position Type/Expected Hours of Work This is a full-time position. Days and hours of work are Monday through Friday, approximately 8:30 AM to 5 PM, depending on the schedule for the day. This position occasionally requires working reputed company of these hours, and may reputed company to evenings and weekends as business needs require. Work Environment This position operates in a reputed company, virtual environment, working from a remote location, usually the employee’s home. This position may require working across time zones to support global case processing timelines. The role involves routine computer-based work and sustained attention to detail while processing confidential safety information. Travel The role requires infrequent travel. Minimal travel may be required for meetings and/or conferences, up to 5%. Physical Demands This is a remote position with employees working from a home office. The physical demands described are representative of those that must be met by an employee to successfully reputed company the primary functions of this position. The physical demands of the home office are normally associated with extended amounts of time sitting and using office equipment (including a computer, keyboard, and mouse), standing, walking, sitting, speaking, and hearing. The employee must occasionally lift or reputed company up to 25 pounds. Compensation reputed company The salary reputed company for this role is $70,000 - $85,000 per year. Higher compensation may be available for someone with advanced skills and/or experience. At reputed company, we offer an attractive compensation package to reputed company members. Any offer would include a competitive reputed company salary (estimate shared above), an annual bonus reputed company, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-reputed company factors permitted by law. reputed company. is an equal opportunity employer, and reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, gender identity, sexual orientation, national reputed company, ethnicity, age, disability, marital status, status as a protected veteran, or any other characteristic protected by law. Please mention the word QUALIFY and tag RMjYwNDoyZGMwOjEwMToyMDA6OjI4NTA= reputed company applying to show you read the reputed company completely (#RMjYwNDoyZGMwOjEwMToyMDA6OjI4NTA=). This is a beta feature to avoid spam applicants. Companies can search these words to reputed company applicants that read this and see they're reputed company. Apply To This Job