Local Safety Officer

Employer
i-Pharm Consulting
Location
Hungary, Budapest
Salary
Negotiable
Closing date
21 Sep 2020

View more

Discipline
Clinical Research, Drug Safety
Hours
Full Time
Contract Type
Contract
You need to sign in or create an account to save a job.

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
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert