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.

Requirements

• Education: Pharmacy, life science or healthcare degree

• Desirable: Higher degree or medical qualification.
• Minimum 2 years of experience in ICSR processing, safety data management and safety data entry, gained within the pharmaceutical industry or with a CRO.
• Knowledge of ICH GCP and other relevant regulations and guidelines
• Knowledge of industry-standard safety databases, such as Oracle Argus, ARISg or AB Cube SafetyEasy.
• Good organizational and interpersonal skills, attention to detail.
• Good communication (oral and written) and analytical skills.

Benefits

• Competitive Salary

• Flexible working hours
• Holidays (Annual leave, Casual leave, Sick leave plus bank holidays)
• Medical Insurance for Self and Immediate Family
• Grautity
• Accidental Coverage
• Quanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e-learning, job shadowing)

Quanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance