Medical Writer I

2+ years

Not Disclosed

India Remote

10 Dec. 5, 2024

Job Description

Job Type: Full Time Education: PhD/BSc/MSc/DPharma/PharmD/MBBS/BDS/BAMS/BHMS/MD 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

Aggregate Report Specialist – Regulatory & Pharmacovigilance
Location: Remote (Global)

Job Purpose:
This role is responsible for managing both scheduled and unscheduled aggregate safety reports, such as Periodic Safety Reports (PSRs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Safety Update Reports, and other regulatory safety documentation. The position involves preparing clinical narratives, ensuring quality and compliance of submitted reports, conducting signal detection, and managing the overall submission process. The role also entails collaborating with cross-functional teams and acting as a primary client contact to ensure high-quality and timely report delivery.

Key Responsibilities:

Aggregate Reports Management:
- Prepare, update, and merge various reports such as PSURs, PBRERs, DSURs, RMPs, and more in line with client and regulatory requirements.
- Conduct critical appraisals and systematic reviews of literature for inclusion in safety reports and Risk Management Plans.
- Generate line listings, identify discrepancies, and resolve them to ensure data integrity and consistency.
- Distribute final reports to stakeholders in compliance with timelines and regulatory standards.
Clinical Study Report Narratives:
- Write clear and accurate clinical study narratives based on clinical database outputs, ensuring medical cohesiveness and regulatory alignment.
- Perform quality checks to ensure narratives meet internal and external guidelines.
Signal Detection and Management:
- Conduct signal detection and evaluation, utilizing qualitative and quantitative analyses from multiple data sources.
- Lead signal management processes, including tracking, assessing, and presenting findings in collaboration with safety science teams.
General Responsibilities:
- Maintain knowledge of drug safety profiles, client guidelines, international regulations, and adverse event reporting obligations.
- Participate in audits, inspections, and training sessions to ensure compliance with regulatory and client standards.
- Act as the primary client contact, ensuring high-quality work and effective communication throughout project lifecycle.
- Mentor and train new recruits, when applicable, and support ongoing development of team members.

Skills and Experience:

Strong analytical and problem-solving skills with the ability to manage multiple tasks effectively.
Excellent interpersonal and communication skills, with a focus on teamwork and client relations.
Proven experience in regulatory, pharmacovigilance, or a related field, with knowledge of medical terminology.
Ability to evaluate data, draw conclusions independently, and provide clear synopses.
Fluency in written and spoken English; proficiency in MS Office and familiarity with web-based applications.

Education:

A university degree in Life Sciences, Health, or Biomedical Sciences (e.g., Pharmacy, Biochemistry, Microbiology, etc.).
A degree in Medicine, Dentistry, Physiotherapy, or related clinical fields is advantageous.

#LI-REMOTE
This position is remote, offering flexibility to work from any location, while contributing to high-quality pharmacovigilance and regulatory reporting processes.

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Medical Writer I

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