Offer summary

Qualifications:

Advanced degree in life sciences or related field., Expertise in pharmacovigilance processes and safety data management., Strong analytical skills and experience in epidemiological methods., Excellent leadership, communication, and problem-solving abilities..

Key responsibilities:

Oversee the end-to-end signal management process and collaborate with client safety science.

Prepare and manage safety documents including Risk Management Plans and Periodic Safety Update Reports.

Conduct literature appraisal and develop search strategies for safety evaluations.

Train junior staff and manage processes while acting as a subject matter expert.

Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

The Principal Medical Writer is responsible for comprehensive signal management, including detection, analysis, and evaluation from various sources. They oversee the end-to-end signal management process, collaborate with client safety science , and adhere to client-defined plans and SOPs. The PMW also contributes to preparing, updating, and managing various safety documents including Risk Management Plans (RMPs), Periodic Safety Update Reports (PSURs), and other aggregate reports. This position requires expertise in pharmacovigilance processes and the ability to manage complex safety data.

They conduct critical appraisal of literature for epidemiological data, develop search strategies, and apply epidemiological methods to support safety evaluations. The role involves generating line listings, maintaining Expected Term Lists, and performing quality reviews of aggregate reports. The specialist manages report distribution, handles safety assessments and affiliate requests, and performs QC of Reference Safety Information for clinical trials. They also update and manage content for Pharmacovigilance manuals, contribute to MedDRA updates, and coordinate meetings related to pharmacovigilance activities.

This role also focuses on training junior staff, managing processes, and acting as a subject matter expert. They will collaborate with clients, identify team concerns, and support senior management in project activities. The position requires strong leadership, communication, and problem-solving skills, balancing mentoring with project management and client relation and requires expertise in pharmacovigilance, strong analytical skills, and the ability to collaborate across functions to ensure comprehensive product safety management across multiple therapeutic areas.

Required profile