Recruiting.com

Manager, Local Pharmacovigilance

Recruiting.com

full-time

Posted on:

Location Type: Remote

Location: 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.
  • 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 proceduresliterature searchPSURRMPcompliance
Soft Skills
communicationcooperationreportingtrainingoversightliaisonescalationorganizationavailabilityparticipation