Medical Writer Ii

Parexel

2+ years

Not Disclosed

Bengaluru Hyderabad

10 March 3, 2025

Job Description

Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Medical Writer II
Location: SAS Nagar (Mohali), India
Additional Locations: Bengaluru, Karnataka, India; Hyderabad, Telangana, India; SAS Nagar (Mohali), Punjab, India

Job Purpose:

Responsible for managing scheduled and unscheduled aggregate reports, including but not limited to:

Periodic Safety Reports (PSRs)
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Addendum to Clinical Overviews (ACOs)
Semi-Annual Safety Reports (SASRs)
Corporate Addendum Reports
United States Periodic Adverse Drug Experience Reports (PADERs)
Development Safety Update Reports (DSURs)
Annual Risk-Benefit Evaluation (ARBE) Report
Risk Management Plan (RMP)
Safety statements, Health Hazard Evaluation (HHE), Drug Safety Report (DSR), Clinical Overview (CO), Safety Evaluation Report (SER), Investigational New Drug Annual Report (INDARs)
Preparing document comparisons between local and global labeling (if applicable)
Checking International Non-proprietary names (INNs) for inclusion in a PSR
Signal detection and management (where applicable)

Key Responsibilities:

Aggregate Reports:

Preparing/updating/merging RMPs/Company Core-RMPs (CC-RMPs).
Preparing health authority response documents and RMS updates.
Conducting systematic literature reviews to include epidemiological data in drug safety reports.
Developing literature search strategies for safety reports.
Applying epidemiological methods to assess data in literature.
Generating line listings for submissions and ensuring resolution of discrepancies.
Performing compliance activities including quality review of various aggregate reports.
Distributing final reports to stakeholders and submitting to health authorities.
Scheduling and coordinating meetings, drafting agendas and minutes, tracking action items.

Clinical Study Report Narratives:

Coordinating with the Study Management Team (SMT) for narrative template development.
Serving as the primary client contact for narrative writing.
Preparing accurate narratives based on clinical and safety database outputs.
Performing quality checks and ensuring cohesiveness in narratives.
Supporting CSR narrative review with SMT.

Signal Detection and Management:

Performing signal detection reviews and qualitative/quantitative analysis.
Leading the end-to-end signal management process.
Supporting signal detection and evaluation activities in line with SOPs.

General Responsibilities:

Maintaining a thorough understanding of adverse event safety profiles, regulations, and guidelines.
Ensuring compliance with internal and regulatory timelines.
Participating in audits and inspections.
Striving for client satisfaction based on feedback.
Mentoring new team members as needed.
Archiving source documents and responding to client queries in a timely manner.
Participating in process improvement and training initiatives.

Skills & Competencies:

Analytical and problem-solving skills.
Excellent communication skills (verbal and written).
Strong organizational and prioritization abilities.
Attention to detail and accuracy in documentation.
Ability to work collaboratively in a team.
Client-focused approach to work.
Strong knowledge of medical terminology.
Fluency in English (written and spoken).
Proficiency in MS Office and web-based applications.
Awareness of global regulatory requirements.

Knowledge & Experience:

Experience in Regulatory/Pharmacovigilance or a related field preferred.
Strong knowledge of medical terminology.

Education:

Required: University degree in Life Sciences, Health or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
Preferred: Degree in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing (with hospital-based exposure).

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