Senior Pharmacovigilance Associate

Quanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers needs.

Our customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development

We strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.

We are looking for Senior Pharmacovigilance Associate to conduct and assist with ongoing pharmacovigilance operational activities in relation to data entry and processing of Individual Case Safety Reports (ICSRs), according to required SOPs, regulations, contracts and quality

standards, under the direction of the Quanticate Team

Key Duties of Role:

• Assist with the processing of case (Spontaneous, literature and clinical) as required in compliance with applicable regulations and Quanticate SOPs, and as requested by the Pharmacovigilance Scientist or above. Prepare case narratives as appropriate.
• Triage of cases for completeness, accuracy and redaction, determining expectedness against the reference safety information and appropriateness for expedited reporting.
• Prepare and submit case notifications to customers. Identify and send case follow-up requests.
• Entry of safety data onto the safety databases and tracking systems. Maintain a strong understanding of the Quanticate safety database conventions or client specific database conventions, as appropriate
• Coding of adverse events, medical history and medications either manually or using the auto-encoder.
• SAE reconciliation between the clinical trial (Case Report Form) and safety databases.
• Assist with weekly and ad-hoc global literature searches as required and as requested by the PV Scientist or above, ensuring adherence to timelines and processes specified in SOPs and project-specific Safety Plans.
• Assist with review and classification of literature abstracts and articles under the supervision of the PV Scientist or above.
• Ensure any ICSRs or safety concerns identified in the literature are logged and processed.
• Assist in the validation of the Safety Database by performing and documenting User Acceptance Testing.
• Support the Pharmacovigilance Lead on assigned projects as appropriate, generating first drafts of project documentation including Meeting Minutes and Serious Adverse Event report forms.