Senior Pharmacovigilance Officer

A speciality pharmaceutical company in Berkshire is seeking a Senior Pharmacovigilance Officer. This role with will have responsibility for pharmacovigilance for all company products, ensuring company compliance inline with MHRA/EU regulations and to provide training in matters of drug safety and medical/product information.

Responsibilities:

• Generation of PSURs in line with UK/EU requirements and Maintains PSUR schedule.
• Prepares expedited report and handles AE follow-up requests
• Support PV Manager in developing and executing QA PV strategy and implementing associated Quality Management System
• Contribute to evaluation of corrective and preventative action (CAPA) findings to identify quality-related signals and trends for improvement
• Reconciliation of ADR and MI reporting.
• Contribute to the development and implementation of strategic audit plans for pharmacovigilance activities that include service providers, vendors, business partner, and internal audits

Requirements:

• Experience in EU pharmacovigilance within either a research and development or established products environment
• Case Processing and drug safety report writing experience
• Knowledge of Good Pharmacovigilance Practices (GVP), Good Clinical Practice (GCP), Good Distribution Practices (GDP), and Good Laboratory Practices (GLP)
• Relevant experience in the pharmaceutical industry
• Extensive Compliance, Quality and auditing experience.

Salary and benefits:

• Competitive salary and bonus
• Extensive benefits package