SPE-Pharmacovigilance

Job Summary

Serve as a specialist professional in pharmacovigilance within a hybrid work model supporting pharma research and development activities focused on the safe and effective use of medicinal products. Contribute to data driven safety evaluation and collaborate across functions to enhance patient safety outcomes and regulatory compliance.

Responsibilities

• Perform end to end case related pharmacovigilance activities that support ongoing pharma research and development and help ensure timely safety reporting to regulatory bodies
• Review available clinical and post marketing safety information to identify potential safety signals and contribute to risk assessment activities that protect patients
• Analyze safety data using company systems to detect trends or patterns and escalate relevant findings to medical safety experts for further evaluation
• Document all safety case handling steps with clear and accurate narratives that enable transparent audits and inspections by internal and external stakeholders
• Collaborate with cross functional research and development teams to integrate safety insights into study design and product lifecycle decisions that advance therapeutic innovation
• Coordinate with quality and compliance teams to follow current pharmacovigilance procedures and support continuous improvement of standard operating processes
• Support preparation of safety sections for regulatory submissions and periodic reports so that product safety profiles are clearly communicated and well justified
• Contribute to knowledge sharing sessions with peers to promote consistent case processing practices and strengthen the overall pharmacovigilance capability of the organization
• Engage with internal technology and data teams to refine pharmacovigilance tools so that safety data capture and retrieval become more efficient and reliable
• Participate in internal audits or readiness activities by providing case related documentation and clarifications that demonstrate strong adherence to pharmacovigilance requirements
• Adapt work practices to a hybrid model by using digital collaboration platforms that maintain continuity of pharmacovigilance operations across onsite and remote settings
• Support broader company goals by transforming safety data into meaningful insights that guide responsible use of medicines and create a positive impact on public health
• Manage personal workload within day shift expectations to ensure all assigned safety activities and timelines are met without the need for travel

Qualifications

• Possess a degree in life sciences pharmacy medicine or a related discipline that provides a solid scientific foundation for evaluating drug safety information
• Demonstrate two to four years of focused experience in pharma research and development with direct exposure to pharmacovigilance practices and processes
• Apply working knowledge of safety data review tools or databases to manage cases efficiently while maintaining data integrity and traceability
• Utilize familiarity with pharmacovigilance data management concepts to support accurate entry reconciliation and retrieval of safety information when required
• Exhibit practical understanding of pharmacovigilance case processing steps including intake coding assessment and follow up activities that align with current regulations
• Communicate clearly in written and spoken form with global stakeholders to ensure that complex safety issues are documented and discussed in an accessible manner
• Show commitment to ongoing learning about evolving pharmacovigilance guidelines and research methodologies so professional skills remain current and adaptable

Certifications Required

Desired certification in pharmacovigilance or drug safety such as a recognized pharmacovigilance professional credential