Knowledgeable Pharmacovigilance scientist with strong background in pharmacovigilance. Effectively managed safety data and contributed to regulatory submissions, ensuring compliance with industry standards. Demonstrated analytical skills and attention to detail in identifying and mitigating risks, while displaying excellent communication abilities for cross-functional collaboration.
• Management of activities related to the processing (case validation, duplicate detection,
identification and creation of split cases (where required), data entry in the Safety
Database) of ICSRs in accordance with the applicable Pfizer and regulatory requirements
• Performing Medical Dictionary for Regulatory Activities (MedDRA) coding in accordance
with “MedDRA Term Selection: Points to Consider”
• Ensuring high quality of assigned work in accordance with Pfizer and CONTINUUM quality
parameters
• Being well-versed with safety profile of assigned vaccines and drugs, ICSR processing
conventions, guidelines, Pfizer procedures and international safety regulations, as
applicable
• Organizing workload to ensure compliance with internal and regulatory timelines
• Interacting with internal or external contacts to resolve queries and issues related to the
assigned work
• Providing support in audits, inspections and inspection readiness activities, as required
• Performing additional activities, as directed
Fluency in spoken and written English
Good communication skills
Good knowledge of medical terminology
Ability to understand, interpret and evaluate data
Attention to detail
Ability to work in a team
High level of flexibility and ability to prioritize work
Awareness of global culture