[Hiring] Manager, Local Pharmacovigilance @Cencora

Role Description

• 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 (where applicable)
• Setting up Local Organized Data Collection
• Local PVA Management
• Local adaptation and submission of PSUR / RMP (where applicable)
• Local signal detection (where applicable)
• 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.

Qualifications

• Bachelor's degree in life sciences, pharmacy, chemistry, biomedical sciences, engineering, quality management, or a related field, or equivalent experience required.

Requirements

• 2+ years of experience in regulatory affairs, quality assurance, compliance, documentation control, or a related field required.
• Certification in regulatory affairs, quality management, compliance, auditing preferred.
• English business fluent & local language: Latvian, Estonian and Lithuanian.

Benefits

• Competitive annual bonus
• Life insurance from Day 1
• Best-in-class health insurance package
• Up to 6 fully paid benefit days a year
• Referral bonus scheme
• Boundless learning opportunities
• Global Employee Assistance Program
• Wonderful office location in Quadrum, equipped with everything you need for a small break at work and fresh snacks at all times