Manager PV Operations

Manager PV Operations

Daiichi Sankyo Europe

Munich, Germany

Purpose of the function

This position functions as an expert in case management within PV Operations, including the oversight and mentoring of junior staff, and vendor management. This position will work both globally and regionally, and will assist more senior levels with process management initiatives as appropriate. This position will also provide support to ensure that daily business is fully executed, and compliance targets are met. It is anticipated that this role is primarily focused on process management initiatives.

Roles and Responsibilities

• Support daily workflow monitoring and managing of incoming and outgoing ICSRs
• Manages complex internal and external ICSR queries
• Provides case mentorship to PV Operations Associate
• Develops and delivers training material
• Responsible for SAE reconciliation
• Perform oversight of safety data reconciliation
• Case processing oversight of CRO/vendor, including case quality review
• Performs in-line QC of ICSRs
• Handles complex spontaneous and clinical ICSR issues
• Oversight of ICSR submissions
• Maintenance of tracking information
• Performs safety data reconciliation (with vendors, partners and affiliates)
• Identifies process deviations and participates in the generation of CAPA

Further Roles and Responsibilities

• Prepares and reviews CAPA
• Participates as an SME in audits and inspections
• Proactively identifies areas of potential improvement and process optimization and suggests potential solutions
• Implements changes to working procedures as a result of process improvements and/or changes to regulatory requirements
• Supports regular update of SOPs in accordance with regulatory requirements
• Leads and/or supports projects based on area of expertise
• Escalates issues to experienced colleagues, the Senior Manager PV Operations and the PV Operations Lead
• Interacts with the CSPV team and has interactions with DS affiliates, cross-functional departments and external partners

Education & Experience

Education:

• Bachelor’s degree at minimum required (Life Science, Pharmacology, Medicine) and minimum of 5 years’ or total of 7 year experience in PV; may also have an advanced degree

Experience:

• Strong understanding of European and International PV regulations
• Experienced in area of case management and CRO Oversight within PV Operations

Skills and additional Requirements

• Excellent computer skills
• Excellent knowledge of English
• Highly reliable
• High attention to detail
• Positive attitude
• Team player with excellent analytical problem-solving skills
• Very good communication skills, including cross-culturally
• Ability to work to deadlines and when under high pressure
• Works independently

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Germany      Clinical Research      On-site      Pharmacovigilance and Medical Information      Daiichi Sankyo Europe