Quality & Process Specialist

Katalyst Healthcares & Life Sciences

5-7 years

Not Disclosed

Bridgewater

10 July 19, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Entry Level Positions in Drug Safety and Pharmacovigilance and Clinical Research

Company: Katalyst Healthcares & Life Sciences

Location: Various locations, working with University hospitals, pharmaceutical companies, and recruiting partners

Type: Full-time, Contract

Company Description:

Katalyst Healthcares & Life Sciences is hiring entry-level candidates for several positions in contract research involving clinical trials of drugs, biologics, and medical devices. We collaborate with university hospitals, pharmaceutical companies, and recruiting partners.

Job Description:

Responsibilities:

Quality Assessment:
- Under the supervision of the PV QTC QC/QA Head, perform quality assessments on the content of data/output and key Pharmacovigilance activities.
- Measure compliance to process, process effectiveness, and data quality as pre-identified in the quality plan.
- Investigate issues, identify root causes, and propose Corrective Action Plan Activities (CAPA).
- Participate in CAPA implementation and ensure monitoring activities to measure effectiveness.
Continuous Improvement:
- Participate in the GPE Quality continuous improvement and Operational excellence programs.
- Track the added value and success of such initiatives.
Risk Detection:
- Detect processes at risk requiring further quality assessments in the Pharmacovigilance network.
Collaboration:
- Interact with CMQ&O auditors, GPE PV Affiliates Relations group, and other functions to provide input on audit/visit actions in affiliates PV units.
- Collaborate with any GPE units involved in the reviewed activity and generating data/outputs to discuss findings and propose consistent corrective action plans.
- Provide input or receive feedback on findings from the User Support group.

Requirements:

Analytical Skills:
- Strong analytical skills with the ability to ensure scientific rigor and good quality in all analyses.
- Sound risk-based judgment in decision-making.
Communication Skills:
- Excellent writing and communication skills.
- Strong interpersonal skills to interact with individuals of various backgrounds and levels.
Independent Work:
- Ability to work independently and manage multiple priorities simultaneously.
- Ability to identify gaps in quality issues and investigate root causes.
Corrective Action:
- Demonstrated ability to participate in the creation of corrective action plans and monitor their effectiveness.
Technical Skills:
- Computer literacy (Microsoft Office).
- Good understanding of Quality Management Systems and their implementation.
- In-depth knowledge of international Pharmacovigilance requirements (US FDA, EMEA guidelines, ICH/CIOMS).
- Experience in quality management, QA, audits, and CAPA methodology would be a plus.
- Understanding of database organization and documentation systems would be a plus.

Education:

Minimum Experience:
- 5 to 7 years in International Pharmacovigilance activities including case processing and interaction with affiliates.
Certified Health Professional Degree Required:
- Examples include Pharmacist, PharmD, or Bachelor of Nursing degree.
Knowledge:
- Demonstrated understanding of Pharmacovigilance processes, PV database systems, and dictionaries.
- Knowledge of international regulations and guidelines (ICH, CIOMS, EMEA/FDA).

Additional Information:

All information will be kept confidential according to EEO guidelines.

For more information or to apply, please visit Katalyst Healthcares & Life Sciences.

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Quality & Process Specialist

Job Description

Job Title: Entry Level Positions in Drug Safety and Pharmacovigilance and Clinical Research

Responsibilities:

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