Drug Device Safety Officer I

19 hours ago

Romania Premier Research Full time 25,000 - 35,000 per year
Premier Research is looking for a Drug Device Safety Officer I to join our Pharmacovigilance and Records Management team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

  • We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

  • Your ideas influence the way we work, and your voice matters here.

  • As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing:

  • Ensure compliance and adherence to all internationally recognized standards (e.g., ICH GCP, ICH E2A etc.), national regulations and SOP's applicable for specific projects.

  • Review incoming SAEs for accuracy, completeness and potential safety issues.

  • Work closely with Investigator Sites/CRAs to document and clarify outstanding event issues in preparation for submitting follow-up reports.

  • Drafts narratives per guidelines and/or individual contract agreements

  • Enters relevant data from safety reports to safety database.

  • Complete SAE management and safety reporting for approximately 90% of billable time.

  • Work with Data Managers / Medical Directors/CRAs during the reconciliation of AE/SAE databases prior to client data delivery.

  • Assure that documents are filed according to standard filing system (paper and electronic) for all contracted studies.

  • Support preparation of draft Safety Management plan and review SAE Reconciliation Plans.

  • Support preparation for audits and inspections by sponsors or regulatory agencies

  • Track study progress, proactively identify issues and propose corrective action to the Safety Manager and PV team

What We Are Searching For:

  • Bachelor degree or graduate in medical or related fields (e.g. medicine, nursing, pharmacy, life sciences), advanced degree preferable.

  • 0-2 years in a relevant pharma or medical related field or role eg. CRA, Pharmacy etc.

  • Knowledge of ICH / GCP regulations

  • Working knowledge of FDA Guidance Documents / EU Directives / ISO 14155 standard, drug / device development, and clinical monitoring procedures

  • Knowledge of web based communication tools for conferences

  • Fluent verbal and written English as well as the local language(s)

  • Excellent team player, collaborative and able to build an effective team. · Ability to multitask and work effectively in a fast-paced environment with changing priorities.

  • Strong verbal and written communication and negotiation skills.

  • Excellent organizational and time-management skills, able prioritize work to meet deadlines.

  • Accountable, dependable and strong commitment.

  • Is customer service focused in approach to work both internally and externally

  • Maintains a positive, results orientated work environment

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