SPE-Pharmacovigilance

Job Summary

As a Senior Process Executive in pharmacovigilance, you will support high-quality pharmaceutical research and development activities that enable the safe and effective use of medicinal products. This hybrid position centers on structured, case-related workflows and scientific documentation. You will produce reliable patient safety insights and help ensure regulatory compliance, contributing to global healthcare impact while working in a day-shift office environment.

Responsibilities

• Carry out end-to-end pharmacovigilance case handling by using structured pharma research and development processes to maintain accurate, compliant safety data management across global studies.
• Review source medical information and study documentation in detail to identify and extract relevant clinical facts that enable dependable product safety profile assessment and risk-benefit evaluation.
• Develop clear, organized case narratives and summaries that help medical and scientific teams understand key patient safety concerns and support evidence-based safety decisions.
• Complete consistent internal quality checks for data entry and documentation related to assigned pharmacovigilance activities to reduce errors and strengthen readiness for regulatory inspections.
• Work closely with cross-functional partners in safety operations and clinical research to synchronize case-handling priorities and support seamless information flow throughout pharmacovigilance processes.
• Assist in the timely completion of safety-related activities connected to pharma research and development milestones, ensuring regulatory commitments and internal delivery timelines are met without delays.
• Follow standard operating procedures and global pharmacovigilance guidelines in daily work to sustain strong compliance and lower operational risk for the organization.
• Maintain precise case tracking information and status updates for assigned cases and tasks within relevant safety and operational systems to enable transparent reporting and workload planning.
• Support continuous improvement by sharing observations about process gaps and proposing practical enhancements that improve data quality and throughput in case management.
• Contribute effectively to hybrid work by leveraging secure digital tools and coordinating scheduled office presence to ensure effective communication, documentation, and oversight of assigned responsibilities.
• Follow day-shift schedules and workload expectations while remaining flexible in managing priority case activities within defined working hours.
• Advance the company mission to improve global patient outcomes by ensuring that safety information produced through pharma research and development is complete, reliable, and ready for regulatory and clinical use.
• Demonstrate sound ethical judgment and strong attention to detail across all case-related activities to protect patient confidentiality and reinforce trust in the company and the broader healthcare ecosystem.

Qualifications

• Demonstrate hands-on experience in pharma research and development processes, including familiarity with study documentation, safety data collection, and scientific reporting practices.
• Show practical exposure to pharmacovigilance case processing tasks such as intake coding, data validation, and narrative preparation, even if experience is limited or still developing.
• Apply working knowledge of individual case safety report concepts and submission workflows to support accurate preparation of case information for downstream safety and regulatory use.
• Use basic understanding of literature screening approaches to identify potential safety signals and extract relevant information from scientific publications that may inform ongoing evaluations.
• Exhibit strong analytical and documentation skills, including the ability to interpret medical information from multiple sources and translate it into structured, consistent pharmacovigilance outputs.
• Communicate clearly in written and verbal formats with medical and operational stakeholders to discuss case details, clarify requirements, and support coordinated safety-related decisions.
• Be comfortable operating in a hybrid work setting by managing tasks across office and remote environments while maintaining confidentiality, productivity, and adherence to company policies.
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• Certifications Required
• Preferred certification in pharmacovigilance or drug safety, such as a postgraduate pharmacovigilance program or equivalent industry-recognized training.