Recruiting.com

Manager, Local Pharmacovigilance

Recruiting.com

full-time

Posted on:

Location Type: Office

Location: Bratislava • Slovakia

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About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
pharmacovigilancelocal ICSR collectionsignal detectionrisk minimization measurespost-authorization safety studiespharmacovigilance procedureslocal PSMF maintenancedata collectionliterature searchaudits and inspections
Soft Skills
communication skillspresentation skillsproblem-solvingcollaborationreportingtrainingliaisonoversightadaptabilityavailability
Certifications
university degree in Life Science