Associate I Pss
3 days ago
**Associate I PSS (Patient Safety)**
Are you looking for a new start within patient safety & pharmacovigilance? Are you perhaps working in a pharmacy/hospital setting, involved in drug safety and now looking to advance your career in a global business? Are you looking for a 100% homebased role?
In a varied role, you will be responsible for assisting with the smooth running of the PSS Department to ensure all adverse events are processed to the required standard and submitted to the client and the regulatory agencies (if required) within the agreed upon timelines.
**Duties and Responsibilities**:
- Assist in or complete per the Safety Management Plan (SMP) the processing of all adverse event reports from any source.
- Assist in producing queries of safety data for clients as appropriate.
- Assist in the generation and maintenance of the PSS metrics.
- Assist Data Management or clients on reconciliation of safety databases.
- Provide input for monthly status reports.
- Maintains a comprehensive understanding of Standard Operating Procedures (SOPs), Work
- Instructions (WI), guidance documents and directives associated with safety management, reporting and pharmacovigilance.
- Possess knowledge of other procedural documents, e.g., SOPs, and how they impact safety.
- Build and maintain good PSS relationships across functional units.
- Demonstrate role-specific Core Competencies on a consistent basis.
- Demonstrate company Values on a consistent basis.
- Assist in the preparation of client meetings and liaise with clients where appropriate.
- Assist with the set-up of, and the provision of data to, Safety Committees/DSMBs.
- Any other duties as assigned by management.
**Experience**
**Required**:
- High degree of accuracy with attention to detail.
- Functions as a team player.
- Good communication.
- Good written and verbal communication skills.
- Ability to work independently with moderate supervision.
**Education/Experience**
**Required**:
- Non-degree + relevant experience** (or 1 yr safety experience) *
- Associates Degree + 2 yrs relevant experience** (or 1 yr safety experience) *
- Degree preferred (but not necessary) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry.
- Safety experience includes actual experience processing AE/SAE reports, generating narratives, queries, working within safety databases, and experience with regulatory submissions.
**Relevant experience includes experience in the pharmaceutical, biotechnology, or CRO industry, partly in related areas such as Medical Affairs, Clinical Data Entry and Clinical Data Management, Clinical Data Monitor, Regulatory Affairs, or Quality Assurance.
**Labcorp is proud to be an Equal Opportunity Employer**:
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
For more information about how we collect and store your personal data, please see our Privacy Statement.
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