Medical Writer I / Medical Writer II
Medical Writer I / Medical Writer II
Parexel
Job description
Looking to build a career in patient safety and pharmacovigilance writing? Explore this Medical Writer I or II, Patient Safety role at Parexel, across Hyderabad, Bengaluru, Mohali, or remote in India.
Company Description
Parexel is a global clinical research company. It helps life sciences firms run clinical trials and offers consulting and regulatory support. The company has over 40 years of experience in healthcare research. Its teams work closely with drug makers and research sites to bring new treatments to patients faster. Parexel moves with urgency, embraces bold thinking, and works to bring new treatments to patients faster.
Job Summary
This role supports pharmacovigilance and patient safety activities across Parexel's Medical Writing team. As a Medical Writer, you will help build regulatory safety documents and manage safety signals for products under review. You will work with cross functional teams, follow industry standard processes, and support safety operations from product conception through lifecycle management. The role can be based on site, remote, or hybrid.
Key Responsibilities
Development and presentation of scheduled and non-scheduled aggregate safety reports like PSURs, PBRERs and DSURs.
Maintain accurate safety documentation, timely submission to regulators in all regions.
Review safety data in databases, literature, and regulatory sites to look for signals of use.
Apply both number based and pattern based methods to spot possible safety signals.
Prepare Drug Safety Reports (DSR) and Signal Evaluation Reports (SERs) with clear conclusions.
Search and review medical literature to synthesize safety data and trends.
Support signal evaluation and epidemiology work through these literature reviews.
Track safety signals and keep signal logs accurate and complete.
Find resolve safety data discrepancies across multiple sources.
Help prepare and update Risk Management Plans in line with safety data.
Keep documents audit ready and store source materials the right way.
Support inspection readiness activities for the company and its clients.
Medical Writer II, coach junior writers on technical and soft skills.
Lead complex client talks and multi person document reviews.
Help improve how the team's processes work.
Educational Qualification
University degree in Life Sciences, Health, or Biomedical Sciences, such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy.
An equal mix of training and work experience can be accepted instead.
Skills Required
Medical Writer I needs 2 or more years of experience in pharmacovigilance, medical writing, or a related field.
Medical Writer II needs 4 or more years of similar experience.
Solid grasp of global pharmacovigilance rules, medical terms, and safety concepts.
Good skills with medical writing tools and MS Office programs.
Familiarity with pharmacovigilance databases and dictionaries e.g. MedDRA and WHO DD.
Strong communication, organizing, and problem solving skills.
Good time management and the ability to juggle several projects at once.
Prior clinical work in hospitals, or hands on clinical research, is a plus.
Deep knowledge of a specific therapy area or product type is a plus.
Knowing pharmacovigilance systems and how submissions work across regions is helpful.
Salary Structure
The average salary for a Medical Writer I at Parexel in India is approximately ₹6 Lakhs to ₹12 Lakhs+ depending on experience and location.
Career Development
Parexel gives medical writers the chance to try new things and grow their skills in both pharmacovigilance and medical writing. The company supports this with work options, regular training and help from managers, at every stage.
How to Apply
Visit our job portal and search for the Medical Writer I or II, Patient Safety role in Parexel.
Click on the listing to view the full job details.
Fill in your information and upload your resume.
Submit your application.
Education
Bachelor's Degree
Key Skills
Market insights & trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.