Local Safety Officer

i-Pharm Consulting
Hungary, Budapest
Closing date
21 Sep 2020

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Clinical Research, Drug Safety
Full Time
Contract Type
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Local Safety Officer

12 month Freelance contract

Candidates must be based in Hungary already

Fluency in English and Hungarian is mandatory

Primary Responsibilities:

· Leading safety data management in case entry, processing (ARGUS) and submission of adverse event reports to the local authority and to Global PhV, as applicable.

- Managing a small team of 4-5 members

· Assists the Lead Local safety officer and Regional PV lead in establishing and maintenance of a local PhV system which includes maintaining understanding of relevant Global and Local SOPs, Work Instructions (WIs), support with maintenance of Local SOPs/WIs and also establishment of local processes to include creation and maintenance of procedural documents.

· Assists in the creation and implementation of the Risk Management Plans (RMP).

· Local Literature monitoring as required

· Electronically file all source documents and other safety-related documents according to internal SOPs.

· Maintains awareness and understanding of latest local regulations on drug safety management in the country and assist in providing PhV training to company employees & local 3rd-parties.

· Preparation and submission of reports for local submissions as applicable.

· Liaise with the QPPV to discuss the next steps, actions from and to the local authorities.

· Responsible for PhV activities such as reconciliation and quality checks with internal and external parties.

· Assists in coordination of PhV activities with local distributors to make sure terms from PhV agreements are being followed.

· Assists in executing CAPAs related to PhV audits & inspection findings.

· Contribute in ensuring PV audit and inspection readiness on an operating company level at all times.

  • Participation in internal audits and supporting external audits.
  • Maintain organisation level quality standards

Secondary Responsibilities:

· Timely support with turnaround as agreed (with data and solutions) + preparation of presentations + solutions that result in excellent customer satisfaction.

· Assist in related administrative and procedural activities as and when required.

· Provide support to preparing weekly/monthly metrics with accurate and verifiable data.

· Provide the updated trackers on time to ensure smooth delivery of the project.

· Provide support to lead on daily deliverables and status report updates.

· Create MOM for the meetings and send it to the lead/Operations Head for approval.

· Any other responsibilities that may arise later in time as a part of project requirement.

· Manage the project offshore

· Preparation of the dashboard and submissions to different stakeholders as required

· Meeting the project SLAs as agreed with the client

Skills / Experience

- Project Management or line management experience of 4 years is ESSENTIAL

· Master's Degree OR University Degree in Pharmacy, Life Sciences or equivalent

· 4+ years' experience in drug safety with strong understanding of PV regulations and requirements for the designated geography

· Possess a high level of business ethics, integrity, and professionalism

· Good communication skills with fluency in English

· Knowledge of good documentation practices, meticulous and has an eye for detail

· Strong "can-do' attitude, self-motivated and has ability to work independently

· Global mindset, preferably with experience working in a multi-national pharmaceutical company

· Adaptable to change in a dynamic working environment, able to manage multiple projects

Life Sciences recruitment is what we do.

We are an award-winning international life sciences recruitment company with offices in London, New York, Munich, Singapore and Sydney.  In a highly competitive market-place, we connect top talent with the very best opportunities.


Our clients include many of the most successful and innovative Pharmaceutical, Biotechnology, and Medical Devices companies, as well as a range of Contract Research & Manufacturing Organisations, Healthcare Agencies and Consultancies.


With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

Contact Us
  • 212 New King’s Road
  • London
  • SW6 4NZ
  • GB
  • +44 (0) 20 3189 2299
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