Local Safety Officer
12 month Freelance contract
Candidates must be based in Hungary already
Fluency in English and Hungarian is mandatory
· 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
· 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