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.