SPE-Pharmacovigilance

About the Role

This hybrid role for a Senior Process Executive in pharmacovigilance focuses on high quality pharma research and development activities supporting safe and effective use of medicinal products. The candidate will work on structured case related processes and scientific documentation enabling reliable patient safety insights and regulatory compliance for global healthcare impact while operating in a day shift office environment.

Key Responsibilities

• Execute end-to-end pharmacovigilance case handling activities by following structured pharma research and development processes to ensure accurate and compliant safety data management across global studies.
• Perform detailed review of source medical information and study documentation to extract relevant clinical facts that support reliable assessment of product safety profiles and risk benefit evaluations.
• Prepare clear and well-organized case narratives and summaries that enable medical and scientific teams to understand key patient safety issues and inform evidence-based safety decisions.
• Conduct consistent internal quality checks on data entry and documentation for assigned pharmacovigilance activities to reduce errors and support robust regulatory inspections.
• Coordinate closely with cross-functional colleagues in safety operations and clinical research to align case handling priorities and support smooth flow of information across pharmacovigilance processes.
• Support timely execution of safety-related tasks tied to pharma research and development milestones so that regulatory commitments and internal delivery timelines are met without delays.
• Apply standard operating procedures and global pharmacovigilance guidelines to daily work activities to maintain strong compliance posture and reduce operational risk for the organization.
• Maintain accurate tracking information and status updates for assigned cases and tasks in relevant safety and operational systems to support transparent reporting and workload planning.
• Contribute to continuous improvement efforts by sharing observations on process gaps and proposing practical refinements that can enhance data quality and throughput in case management.
• Collaborate in hybrid work settings by using secure digital tools and scheduled office presence to ensure effective communication, documentation, and oversight of assigned responsibilities.
• Adhere to day shift schedules and workload expectations while demonstrating flexibility in handling priority case activities within defined working hours.
• Support the company mission of improving global patient outcomes by ensuring that safety information generated through pharma research and development is complete, reliable, and ready for regulatory and clinical use.
• Apply strong ethical judgment and attention to detail in all case-related activities to protect patient confidentiality and sustain trust in the company and broader healthcare ecosystem.

Qualifications

• Demonstrate solid 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 activities such as intake, coding, data validation, and narrative preparation, even if experience is limited or evolving.
• 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 recognize potential safety signals and extract relevant information from scientific publications that may inform ongoing evaluations.
• Exhibit strong analytical and documentation skills with the ability to interpret medical information from diverse sources and transform it into structured, consistent pharmacovigilance outputs.
• Communicate clearly in written and verbal forms with medical and operational stakeholders to discuss case details, clarify requirements, and support coordinated safety-related decisions.
• Operate comfortably in a hybrid work environment by managing tasks across office and remote settings while maintaining confidentiality, productivity, and adherence to company policies.

Certifications

• Preferred certification in pharmacovigilance or drug safety such as postgraduate pharmacovigilance program or equivalent industry-recognized training.