Aggregate Safety Process, Senior Specialist

2+ years

Not Disclosed

Mumbai

10 Nov. 15, 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, 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 Description

Position: Aggregate Safety Process, Sr. Specialist

Overview:
As an Aggregate Safety Process Sr. Specialist, you will ensure high-quality and compliant reporting of aggregate safety reports in accordance with Pharmacovigilance (PV) regulations, ensuring the integrity of aggregate safety reports while maintaining regulatory compliance.

Key Responsibilities:

Perform quality review and compliance monitoring of aggregate safety reports submitted to Health Authorities and Business Partners, ensuring adherence to regulatory requirements.
Measure and track quality effectiveness using key performance indicators (KPIs) and other relevant metrics.
Extract, calculate, and conduct quality control (QC) of patient exposure data for aggregate reports.
Monitor the quality of aggregate safety reports to ensure internal and regulatory compliance.
Collaborate with internal and external stakeholders to identify, prioritize, and address quality and compliance issues, developing solutions to mitigate risks.
Implement emerging regulations to ensure global alignment with quality and compliance activities.
Assess the impact of procedural changes on quality and compliance monitoring activities, updating processes as needed.
Participate in critical pharmacovigilance, IT, and quality initiatives.
Maintain procedural documents related to quality review and compliance activities.
Assist with inspection readiness and preparation as required.
Support the review of regulatory agency responses regarding quality and compliance monitoring.
Develop and maintain tools for streamlining quality and compliance monitoring, implementing automation where possible.
Provide training and support to new team members.
Manage Aggregate Report operations and mailbox.
Contribute to continuous improvement efforts within the process.

Required Qualifications:

Bachelor’s or Master’s degree in life sciences, healthcare, or pharmaceutical-related fields.
In-depth knowledge of PV principles, systems, and regulatory requirements.
Strong analytical skills with a focus on quality and compliance.
Excellent problem-solving, conflict resolution, and critical thinking abilities.
Ability to work autonomously, manage competing priorities, and adapt to changing business needs.
Proficiency in Office 365 applications.
Strong written and verbal English communication skills.
Highly organized with attention to detail and multitasking capabilities.
Proficient in Microsoft Office and relevant IT tools for assigned processes.
Ability to collaborate effectively and build relationships in a cross-functional environment.

About Us:
Organon is a global healthcare company committed to delivering health solutions that enable individuals to live their best lives. We focus on improving the health and well-being of women and their communities, driving innovation in women’s health and biosimilars.

Employment Details:

Employee Status: Regular
Relocation: No relocation provided
Visa Sponsorship: Not offered
Travel Requirements: Must meet credentialing and vaccination requirements for applicable travel.

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Aggregate Safety Process, Senior Specialist

Job Description

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