Periodic Report Planning Expert

2-4 years

Not Disclosed

Hyderabad

10 Aug. 13, 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

About Sanofi Consumer Healthcare (CHC):

At Sanofi Consumer Healthcare (CHC), our mission is clear: to passionately challenge ourselves and our industry daily to build a healthier future by empowering people to take control of their health. We aim to bring "Health in Your Hands" by creating trusted and loved brands that resonate with millions of consumers globally. Our efforts are focused on enabling better self-care, contributing to healthier communities, and ensuring a positive environmental impact. Our commitment to sustainability and social responsibility drives us to act as a force for good across all aspects of our business.

To achieve this, we are engaging our consumers, customers, healthcare professionals, and employees on this journey, striving to become the "Best Fast-Moving Consumer Healthcare (FMCH) Company In & For the World." At Sanofi CHC, we foster a work environment where our people can thrive, grow, and perform at their best every day. Our priority is to work with integrity, improving the health and well-being of the people and communities we serve, and making a positive impact on the world.

Our Team:

The Global Regulatory Strategy & Science Partner Markets Team is dedicated to building a culture of excellence by:

Driving operational effectiveness in regulatory processes.
Enabling strategic decision-making on global regulatory strategy portfolios.
Bridging regulatory portfolio activities with brand needs.
Monitoring regulatory performance and budget.
Ensuring operational excellence and continuous improvement in Partner Markets (G2) for Science.

The CHC Science Center of Excellence (CoE) in India is central to this effort, supporting Science Customer functions globally. We aim to deliver world-class performance and value, offering strategic and tactical support to CHC Science.

Main Responsibilities:

Benefit-Risk Evaluation: Assess the Benefit-Risk profile of Sanofi CHC’s marketed medicinal products to ensure they are safe and effective for patients.
Periodic Safety Reports: Support the preparation of periodic safety reports, including the Addendum to Clinical Overview (ACO).
Project Management: Conduct project kick-off meetings, align line functions on reporting requirements, and manage project activities to ensure timely receipt and incorporation of information into the ACO template.
Report Authoring: Author assigned sections of the ACO and compile the rest by liaising with different line functions. Ensure data validation, quality, and consistency across the document.
Quality Control: Perform peer quality checks, ensure audit readiness, and proactively resolve discrepancies for consistency across the document.
Collaboration: Work effectively with various Sanofi CHC line functions and external partners to deliver high-quality ACOs that meet regulatory standards.
Vendor Coordination: Oversee and provide technical support to vendors, ensuring timely and accurate deliverables.

People:

Maintain strong relationships with stakeholders across line functions to ensure comprehensive aggregate analysis and meet Health Authority requirements.
Lead assigned projects and develop Sanofi CHC Science CoE operations.
Embrace and leverage technological advancements.

Performance:

Ensure timely preparation, archiving, and delivery of periodic safety reports in compliance with Sanofi CHC’s quality standards.
Act as an independent quality reviewer for reports prepared by peers or vendors.

Process:

Contribute to process improvement initiatives, secure adherence to compliance procedures, and support Health Authority inspections/audits.
Mentor new team members, identify training needs, and participate in the development of new tools and initiatives.

Stakeholders:

Work closely with CMO and vendor teams to ensure timely deliverables and liaise with the CMO team to prepare customized reports.

About You:

Experience:

2-4 years in pharmacovigilance, clinical drug development, or related areas.
Preferably, 2+ years of experience in authoring and coordinating periodic safety reports.
Experience in stakeholder management, project management, and operating effectively in a global environment.

Technical Skills:

Proficient in MS Office tools, electronic document management (preferably Veeva-vault), and advanced MS Word functionality.
Strong knowledge of the drug development process, pharmacovigilance, GVP, GCP, and medical terminology.

Education:

Graduate/Post-graduate degree in Pharmacy (preferred) or life sciences.

Languages:

Fluent in English (verbal and written).

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Periodic Report Planning Expert

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