Drug Device Safety Officer II

Premier Research is looking for a Drug Device Safety Officer II 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 80% of billable time.

​Review and approve reconciliation plans as Lead DSO

​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.

​Prepare draft Safety Management Plan for Safety Manager review.

​Prepare for and participate in audits and inspections by sponsors or regulatory agencies

​Track study progress, proactively resolve issues, and propose corrective action to project teams/clients

​Perform quality check of SAEs processed by other DSO, both in paper and in safety database (if applicable)

​Maintain/support maintenance of safety database for specific projects

​Work with Medical Monitor/ Medical Director to determine appropriate assessments with regard to relationship of event to the investigational product and regulatory reporting status of SAEs.

​QC eTMF

​Enter monthly actuals and determine forecasting in Premier Research’s financial tool for accurate study tracking

​Supports preparation of periodic safety reports (periodic line listings, DSURs, ASRs)

​Evaluate safety sections of the protocol and Investigator Brochures (IBs) to ensure the text is compliant with regulations and escalate as appropriate.

​Submit SAE/SUSAR using dedicated submission platforms e.g. Eudravigilance, Toetsing online (if applicable)

​Mentors and trains new employees and other team members

What we are Looking for:

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

2-4 years of working in a medical or safety department with demonstrable knowledge of medical terminology and experience of handling case processing and safety databases (AERS/ARISg/Argus) or equivalent role within medical.

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.