Medical Safety Writer

2+ years

Not Disclosed

Ahmedabad

10 Nov. 11, 2024

Job Description

Job Type: Full Time Remote 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 Title: Medical Safety Writer (MSW)

Location: Global (Remote/Flexible)
Job Type: Full-Time

About Baxter:

At Baxter, our mission drives us every day to save and sustain lives around the world. Every role within our organization directly impacts patient outcomes, whether it's in hospitals, clinics, or homes. For over 85 years, we've led innovations in healthcare that have transformed the way patients receive care and how we approach life-saving treatments. At Baxter, we foster a culture of collaboration, success, and inspiration where you can do your best work and feel a sense of purpose in everything you do.

Role Overview:

The Medical Safety Writer (MSW) plays a critical role in preparing and completing aggregate safety reports for regulatory agencies worldwide. As a part of the Global Patient Safety team, you will be responsible for writing, preparing, and ensuring the timely submission of various aggregate safety reports, including PADERs, PBRERs, PSURs, and other related documents.

Key Responsibilities:

Report Preparation: Write and prepare standalone post-marketing aggregate safety reports (PADERs, PBRERs, PSURs) for regulatory submission, ensuring compliance with applicable regulations.
Quality Control: Conduct quality control reviews of all aggregate safety reports, verifying their accuracy and completeness before submission.
Regulatory Submissions: Ensure timely submission of safety reports according to regulatory requirements and Baxter's internal timelines.
Regulatory Communication: Assist in preparing timely responses to requests from regulatory authorities and responding to safety assessment reports.
Cross-Functional Collaboration: Work closely with Drug Safety Physicians, EU-QPPVs, and GPS Risk Management to address safety issues related to writing activities.
Internal Collaboration: Collaborate with other Baxter functional teams, such as Regulatory Affairs, Clinical/Medical Affairs, Quality, Data Management, and others as necessary.
Process Improvement: Contribute to the development, enhancement, and maintenance of Medical Safety Writing procedures and departmental processes.
Project Involvement: Participate in project teams and committees as assigned.

What You’ll Bring:

Expertise in medical safety writing, with a strong understanding of aggregate safety reports and regulatory submission processes.
Attention to Detail: Exceptional ability to ensure accuracy and completeness in all written documents.
Collaborative Spirit: Proven ability to work effectively with cross-functional teams, including physicians, regulatory teams, and other departments.
Regulatory Knowledge: Understanding of global and regional regulatory requirements related to post-marketing safety reports.
Communication Skills: Strong written and oral communication skills, with the ability to present complex safety data in a clear, concise manner.
Project Management: Ability to manage multiple tasks and deadlines effectively in a dynamic, fast-paced environment.

Education and Experience:

Required:
- Bachelor's degree in Pharmacy, Life Sciences, or related fields.
- Prior experience in Medical Writing, Pharmacovigilance, or related roles with a focus on regulatory reporting.
- Experience preparing aggregate safety reports (PADERs, PBRERs, PSURs) for regulatory submission is highly preferred.
Preferred:
- Advanced degree in a related field (e.g., Master's, PharmD, PhD) is a plus.
- Experience with Regulatory Affairs or Global Patient Safety functions.

Why Baxter?

Joining Baxter means becoming part of a purpose-driven organization where you will be part of a team dedicated to improving the lives of patients around the world. We offer a competitive salary, comprehensive benefits, and a culture that supports professional growth and work-life balance. With a strong commitment to diversity and inclusion, Baxter is where you can truly make a difference.

Reasonable Accommodations:

Baxter is committed to providing reasonable accommodations to individuals with disabilities. If you need any assistance during the application or interview process due to a disability, please contact us with your request.

Recruitment Fraud Notice:

Baxter is aware of fraudulent recruitment activities where individuals posing as Baxter employees attempt to steal personal or financial information. Please ensure you're engaging with authorized Baxter representatives and review our Recruitment Fraud Notice for guidance on how to protect yourself.

How to Apply:

Please submit your CV in English to apply for this role.

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Medical Safety Writer

Job Description

Job Title: Medical Safety Writer (MSW)

About Baxter:

Role Overview:

Key Responsibilities:

What You’ll Bring:

Education and Experience:

Why Baxter?

Reasonable Accommodations:

Recruitment Fraud Notice:

How to Apply:

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