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Manager, Local Pharmacovigilance

Cunesoft

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Location:
Belgium , Mechelen

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Category:
Consulting

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The Manager of Local Pharmacovigilance is responsible for the execution of operational tasks and all aspects of technical delivery and project management in the field of Local Pharmacovigilance.

Job Responsibility:

  • Set up and manage the local pharmacovigilance system
  • Local Literature Search
  • Local ICSR 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
  • 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
  • Deputy is assuming responsibility in case of planned or unplanned absence
  • The employee agrees to take over additional reasonable tasks that align with their abilities, if required

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
  • Leadership: Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads)
  • Task and project management skills: Ability to train and support junior/new colleagues in daily activities
  • ability to lead small project with clearly defined scope
  • (Customer) Relationship skills: Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level
  • Communication & presentation skills: Good communication skills (written and verbally)
  • capability to communicate issues and propose appropriate solutions to decision makers
  • Good presentation skills
  • Language skills: English business fluent & Dutch and French as local languages

Additional Information:

Job Posted:
March 19, 2026

Employment Type:
Fulltime
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