Quality Assurance Lead - Pv

2-4 years

Preffered by Company

Mysore

10 Aug. 26, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, 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: PV Quality Assurance

Location: Mysore - Hybrid

Function: Drug Safety

Company Overview:

Sitero is a rising leader in clinical services and software solutions for the life sciences industry. We specialize in providing innovative, technology-driven solutions across various therapeutic areas, enabling our clients to focus on their core competencies. From early-phase studies to Phase III clinical trials, our expert team offers high-touch services and technology to ensure the safety and integrity of clinical research. We prioritize ethics, compliance, and innovation in all our endeavors.

Position Overview:

We are seeking a dedicated PV Quality Assurance professional to join our Drug Safety team in Mysore. This role is crucial for enhancing the quality of our drug safety processes, identifying potential risks, and preventing quality issues before they arise. The successful candidate will work closely with our safety teams, Contract Research Organizations (CROs), and partners to ensure excellence in pharmacovigilance and safety surveillance.

Key Responsibilities:

Audit Support: Assist with client and regulatory audits in the pharmacovigilance (PV) domain.
Quality Management: Lead and manage the Quality Management Systems for PV.
CAPA Coordination: Collaborate with support groups/functions to develop and execute Corrective and Preventive Actions (CAPAs) based on identified gaps from internal or external audits.
Process Improvement: Support process excellence initiatives, drive improvement projects, and implement best practices in a dynamic environment.
Benchmarking: Identify and implement benchmarking and best practices across projects to enhance efficiency and effectiveness.
Customer Satisfaction: Address potential customer dissatisfaction drivers and proactively mitigate risks to customer satisfaction (CSAT).
Collaboration: Work closely with customers and the operations leadership team to identify and resolve improvement opportunities.
Metrics Management: Ensure compliance with all process metrics and performance indicators.
Consulting: Lead consulting assignments within the PV space to deliver business value through quality initiatives.

Education and Experience:

Required:
- Minimum of 4 years of relevant experience in drug safety or clinical research.
- 1-2 years of experience managing audits and inspections.
- Degree in Life Sciences, Pharmacy, or a related field.
Preferred:
- 4+ years of experience in drug safety and clinical research.
- Familiarity with safety databases and scientific coding browsers such as MedDRA and WHO.
- In-depth knowledge of drug safety and pharmacovigilance regulations, including US and EU guidelines, CIOMS, and ICH standards.
- Experience with safety data collection and interpretation from clinical trials and post-marketing environments.
- Strong organizational, documentation, and interpersonal skills.
- Excellent verbal, written, and presentation skills.
- Innovative and collaborative approach with the ability to influence and build relationships across disciplines.

Compensation & Benefits:

Sitero offers a competitive compensation package, including a variable pay structure, paid time off, healthcare, and retirement benefits.

Employment Type:

Full Time, Permanent

Work Hours:

Standard workweek of 40 hours, Monday through Friday, with one hour for lunch. Additional hours and shift work may be required as needed.

Commitments:

Sitero is an equal opportunity employer and values diversity. All qualified applicants will receive consideration for employment without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

Apply Today:

If you are a proactive, detail-oriented professional with a passion for drug safety and quality assurance, we encourage you to apply and become a vital part of the Sitero team.

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Quality Assurance Lead - Pv

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