Fresenius Kabi Oncology Ltd. is hiring experienced professionals for the position of Medical Writer (Aggregate Report Writing) in Sector 32, Gurugram. This opportunity is suitable for candidates with 1–5 years of experience in aggregate medical writing, pharmacovigilance, drug safety, and regulatory documentation.

Candidates with hands-on expertise in PSUR/PBRER, DSUR, Benefit-Risk Assessment, and Aggregate Safety Reports are encouraged to apply. This Medical Writer job in Gurugram offers an opportunity to work closely with Pharmacovigilance, Medical Affairs, and Regulatory teams.

Job Overview

Key Responsibilities

As a Medical Writer specializing in Aggregate Report Writing, selected candidates will be responsible for:

• Authoring and reviewing aggregate safety reports.
• Preparing and supporting documentation for PSUR/PBRER and DSUR.
• Conducting Benefit-Risk Assessments and interpreting safety information.
• Reviewing scientific literature and identifying relevant safety data.
• Analyzing and summarizing pharmacovigilance and drug safety information.
• Ensuring scientific accuracy and compliance with applicable regulatory requirements.
• Working according to global regulatory guidelines, including ICH, EMA, and FDA requirements.
• Collaborating with Pharmacovigilance, Medical Affairs, Drug Safety, and Regulatory Affairs teams.
• Supporting the preparation of high-quality aggregate medical writing deliverables.

Required Skills and Experience

Candidates applying for this Medical Writer job at Fresenius Kabi Oncology should have:

• 1–5 years of relevant experience.
• Hands-on experience in Aggregate Medical Writing.
• Knowledge of PSUR/PBRER, DSUR, and Aggregate Safety Reports.
• Understanding of Benefit-Risk Assessment methodologies.
• Strong knowledge of Pharmacovigilance and Drug Safety.
• Familiarity with international regulatory guidelines such as ICH, EMA, and FDA.
• Experience conducting scientific literature reviews.
• Ability to interpret, analyze, and summarize complex safety data.
• Strong scientific writing, communication, and documentation skills.

Educational Qualifications

Applicants should possess one of the following qualifications:

• PharmD
• M.Pharm
• M.Sc. in Life Sciences

Why Consider a Career in Aggregate Medical Writing?

Aggregate medical writing is an important area within pharmacovigilance and drug safety. Medical writers contribute to the preparation of periodic safety reports and regulatory documents that help organizations continuously evaluate the safety and benefit-risk profile of medicinal products.

Professionals with experience in PSUR/PBRER writing, DSUR preparation, aggregate safety reporting, and benefit-risk assessment are increasingly valuable in pharmaceutical and drug safety operations.

This role can provide relevant exposure to cross-functional teams, global regulatory requirements, and scientific safety documentation.

Salary and Compensation

The exact salary has not been disclosed by the employer. Based on the role requirements, experience level, and location, the estimated salary for a Medical Writer – Aggregate Report Writing position in Gurugram may range from approximately:

₹4,50,000 – ₹9,00,000 per annum

Actual compensation may vary based on candidate experience, skills, qualifications, and company policies.

How to Apply for Fresenius Kabi Oncology Medical Writer Job?

Interested and eligible candidates can connect with:

• Samruddhi Ghare
• Dr. Piyush Rajput

Candidates can share their updated CV with:

Sonia.kaushik@ext.fresenius-kabi.com