Global Pharmacovigilance Operations Manager

2 weeks ago


Stockholm, Stockholm, Sweden Sobi Full time
Job Title: Global Pharmacovigilance Operations Manager

Job Description:

The Global Pharmacovigilance Operations Manager plays a crucial role in ensuring the effective management of pharmacovigilance operations across the organization. This includes working closely with the Sobi case processing system, as well as vendor processing functions, to ensure the timely and accurate processing of individual case safety reports (ICSRs).

Main Responsibilities:

• Identify opportunities for process improvements and implement changes to optimize case management and vendor oversight

• Develop and implement key performance indicators (KPIs) to monitor compliance and quality standards

• Collaborate with the Systems and Operations team to ensure seamless integration and effective operation of pharmacovigilance systems

• Ensure that all case processing vendor staff are properly certified and trained to meet regulatory requirements

• Proactively identify and address quality and compliance issues, and implement corrective actions as needed

• Provide guidance and support to the Global PV Case Management Lead on regulatory intelligence review impact assessments

Requirements:

• University-level qualification in a relevant field (biosciences, healthcare, or pharmacy)

• At least 3 years' experience in the pharmaceutical industry, with a focus on pharmacovigilance and case processing

• Strong knowledge of GVP and GCP regulations, as well as pharmacovigilance principles and practices

• Excellent communication and project management skills, with the ability to work effectively in a team environment

• Fluency in English, both written and spoken

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