Manager, Local Pharmacovigilance

Role Overview

• Set up and manage the local pharmacovigilance system, including oversight of local PV activities.
• Local Literature Search
• Local ICSR Collection and Management
• PV Intelligence Screening
• Local PSMF Maintenance
• Setting up Local Organized Data Collection
• Local PVA Management
• Local adaptation and submission of PSUR / RMP
• Local signal detection
• Implementation of additional Risk Minimization Measures
• Reviewing materials relating to local post-authorization safety studies
• Participate in PV-relevant audits and inspections
• Attend regular meetings according to project meeting schedule
• Provide monthly PV report on status of local PV system in the country/ies
• Ensure PV training of affiliate employees, service providers and Third Parties
• Close cooperation with the global PV system of the client as well as related global and local departments and functions
• Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures
• Close cooperation with the respective Deputy and providing the Deputy with information on relevant current PV activities
• Identify and escalate any Medical Information requests to an appropriate team according to applicable timelines.
• 24/7 availability with the Competent Authority in the country for pharmacovigilance-related matters.
• Act as official liaison with the Competent Authority in the country for pharmacovigilance-related matters.
• Maintain oversight of local PV system to ensure compliance with national laws and regulations.
• Notify the health authority promptly of significant safety concerns, product recalls or changes in the benefit-risk profile of the products.
• Coordinate the distribution of national safety communications, such as Direct Healthcare Professional Communications.
• Ensure local pharmacovigilance system updates and validations.
• Internally, serving as point of contact for the EU-QPPV and the global PV team.
• Deputy is assuming responsibility in case of planned or unplanned absence.

Requirements

• University degree in Life Science
• Several years’ experience and profound knowledge in the field of pharmacovigilance
• Expertise, experience and knowledge regarding relevant legislative and non legislative guidelines on pharmacovigilance
• Good communication skills (written and verbally);
• Capability to communicate issues and propose appropriate solutions to decision makers.
• Good presentation skills.
• English business fluent.

Benefits

• Benefit offerings outside the US may vary by country and will be aligned to local market practice.
• The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.