Medical Writer (Aggregate Reporting)

We are seeking an experienced Medical Writer to join our Pharmacovigilance and Medical Writing team.

The successful candidate will be responsible for preparing and reviewing complex regulatory and safety documents, ensuring compliance with global regulatory requirements and company SOPs. This role requires strong scientific expertise, analytical thinking, and the ability to provide medical writing leadership on complex projects.

Key Responsibilities

Medical Writing & Regulatory Documentation

• Prepare and review aggregate safety reports and regulatory documents, including:
• PADER
• Risk Management Plans (RMPs)
• Benefit-Risk Evaluation Reports
• Signal Reports
• PSUR/PBRER
• DSURs
• Addendum to Clinical Overviews
• Off-label Use Reports
• PSUSA Responses
• Draft and review responses to regulatory authority requests and enquiries.
• Prepare and validate safety reports produced internally or by Case Management teams.
• Conduct literature analysis and data interpretation to support medical writing activities.
• Ensure all deliverables comply with GVP, ICH guidelines, client requirements, and internal SOPs.

Scientific & Medical Expertise

• Interpret and critically evaluate clinical, biomedical, and scientific data.
• Analyze published and unpublished clinical evidence from multiple sources.
• Provide expert scientific support to internal stakeholders and clients.
• Deliver medical and scientific training to colleagues and cross-functional teams.
• Support medical and regulatory discussions requiring advanced scientific judgment.

Client & Project Management

• Coordinate directly with clients regarding medical writing deliverables.
• Prepare and review aggregate reporting plans.
• Support technical agreements and project estimations for new business opportunities.
• Participate in bid defense meetings and customer discussions.
• Represent the Medical Writing function during audits and inspections when required.

Quality & Compliance

• Contribute to SOPs and Working Practice Documents.
• Support CAPA implementation and continuous process improvement initiatives.
• Monitor quality metrics and regulatory compliance.
• Participate in internal training and quality management activities.

Required Qualifications

Education

• Medical Doctor (MD), Pharmacist, or
• Bachelor’s or Master’s degree in Life Sciences (e.g., Immunology, Microbiology, Bacteriology, or related discipline).
• Academic training in Pharmacovigilance is preferred.

Experience

• Minimum 4 years of experience in Pharmacovigilance.
• Prior experience in Medical Writing strongly preferred.
• Experience preparing aggregate safety reports and regulatory documentation.

Technical Competencies

• Strong understanding of:
• Pharmacovigilance regulations
• GVP requirements
• ICH guidelines
• Benefit-risk assessment
• Signal management
• Aggregate safety reporting
• Ability to analyze and interpret complex scientific and clinical information.

Soft Skills

• Excellent written and verbal communication skills.
• Strong analytical and critical thinking abilities.
• Ability to summarize complex scientific information clearly.
• Client-oriented mindset.
• Strong organizational skills and ability to meet deadlines.
• Team-oriented with coaching and training capabilities.