SPE-Pharmacovigilance

Job Description:

Responsibilities

• Perform pharmacovigilance case intake activities by reviewing source documents verifying completeness of safety information and ensuring accurate capture of relevant medical data to maintain high quality case processing standards.
• Execute detailed case assessment activities by evaluating seriousness causality and expectedness based on clinical and scientific judgment to support consistent safety signal interpretation.
• Document adverse events and product complaints in safety databases by entering structured and narrative information with strong attention to accuracy and consistency to comply with internal and regulatory requirements.
• Collaborate with cross functional colleagues in clinical development medical affairs and regulatory functions by sharing safety insights to support informed benefit risk evaluations for investigational and marketed products.
• Apply pharma research and development knowledge by interpreting clinical protocols investigator brochures and development safety update reports to ensure case evaluation aligns with project objectives.
• Conduct ongoing case follow up by tracking pending information coordinating with partners and updating records to maintain complete and reliable pharmacovigilance data sets.
• Review safety data outputs such as line listings and summary tables by identifying inconsistencies and trends to support aggregate safety reporting and risk management activities.
• Support process improvement initiatives by identifying recurring issues in data entry documentation and case routing to enhance overall efficiency and quality of pharmacovigilance operations.
• Ensure strict adherence to global regulations and internal standard operating procedures by staying current with evolving pharmacovigilance guidance and applying it consistently during daily tasks.
• Utilize pharmacovigilance systems and tools by performing data entry query resolution and quality checks to maintain data integrity and traceability across the safety lifecycle.
• Coordinate with vendor or partner teams where applicable by clarifying case requirements sharing feedback and supporting smooth handoffs to achieve timely and compliant case closure.
• Participate in audits and inspections by providing clear documentation case histories and process explanations to demonstrate robust compliance and quality controls.
• Contribute to a culture of patient safety by highlighting potential safety concerns promoting responsible data practices and supporting improved health outcomes for individuals and communities.

Qualification & Experience

• Possess a degree in pharmacy life sciences medicine or a related scientific discipline with practical experience in pharma research and development supporting clinical or safety activities.
• Demonstrate two to four years of hands on pharmacovigilance or drug safety experience with proven exposure to case processing workflows and safety database usage.
• Exhibit working knowledge of pharmacovigilance data management practices by understanding coding conventions dictionary usage and principles of structured medical data capture.