Safety Medical Writer Job at Merck
A rare chance has emerged for experienced professionals to join Merck Group as a Senior Specialist / Expert – Safety Medical Writer in Bangalore, Karnataka. This full-time position invites candidates with a strong background in pharmacovigilance to contribute to impactful healthcare solutions, leveraging their expertise to enhance patient safety and regulatory compliance. The role promises an engaging work environment where innovation and communication meet dedication.
About Merck Group:
Merck Group is a global leader in science and technology, operating in the healthcare, life science, and electronics sectors. The organisation is dedicated to improving and prolonging lives through innovative medicines, intelligent devices, and technologies. With a diverse workforce across six continents, Merck Group fosters a culture of inclusion and collaboration, providing numerous opportunities for personal and professional growth. Their commitment to excellence and advancement in scientific research makes them a preferred employer for those passionate about making a difference in the world of healthcare.
Job Details:
- Job Name: Senior Specialist / Expert – Safety Medical Writer
- Job Id: 302844
- Location: Bangalore, Karnataka, India
- Job Type: Full-time
Job Description:
The role involves supporting Global Patient Safety (GPS) Safety Scientists and Safety Strategy Leads with safety medical writing (SMW) activities. The position requires collaboration with senior staff to develop sections of a wide range of pharmacovigilance documents and to ensure high-quality deliverables. This involves meticulous attention to detail and a strong understanding of regulatory requirements to produce documents that are not only accurate but also insightful, supporting the overarching goal of patient safety and regulatory compliance.
Key Responsibilities:
- Support GPS Safety Scientists and Safety Strategy Leads with SMW activities, ensuring that all documentation is thorough and aligns with global standards.
- Assist in developing pharmacovigilance documents including Periodic Safety Reports, Signal Assessment Reports, and more, contributing to the comprehensive safety evaluation of products.
- Responsible for proofreading, building and populating tables, and drafting appendices, ensuring that all data is presented clearly and logically.
- Produce high-quality, accurate documents with clear conclusions, aiding in the decision-making processes of the organization.
- Communicate technical, medical, and scientific information effectively within specified timelines, maintaining clarity and precision in all communications.
- Perform quality control of SMW deliverables for data accuracy and consistency, ensuring that all outputs meet the high standards expected by Merck Group.
- Participate in meetings related to key PV activities, providing insights and updates on ongoing projects and documentation.
- Collaborate cross-functionally to improve medical writing standards and best practices, contributing to the continuous improvement of processes and outcomes.
Eligibility Criteria for this Safety Medical Writer Job:
- Graduate degree or equivalent job experience with comprehensive pharmacovigilance knowledge, demonstrating an ability to apply this expertise effectively in a professional setting.
- MD/PhD or advanced science degree preferred, reflecting a high level of expertise and commitment to the field.
- Profound pharmacovigilance experience, including 5 to 8 years in PSRs, showcasing a strong track record of success in similar roles.
Skills Required for this Safety Medical Writer Job:
- Excellent written and spoken English, familiarity with AMA style guide, demonstrating the ability to communicate complex information clearly and effectively.
- Experience in Periodic Safety Reports and safety data interpretation, ensuring a deep understanding of the nuances of safety documentation.
- Strong knowledge of regulations and guidelines (FDA, EMA, ICH, EU GVP, etc.), ensuring compliance and adherence to industry standards.
- Experience with electronic document management systems (EDMS) and benefit-risk assessment, facilitating efficient and effective management of documentation processes.
- Ability to produce high-quality documents and express complex data concisely, ensuring clarity and precision in all written communications.
- Experience in cross-functional, global teams across different regions and time zones, demonstrating adaptability and effective collaboration skills.
- Flexible attitude and adaptability to changes, showcasing a readiness to embrace new challenges and opportunities as they arise.
