Senior Medical Writer

The SMW will be responsible for authoring the signal management reports including Validations, SERs, HA requests etc. The scientist will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management

• Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc.
• Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO.
• Conduct/support signal detection and evaluation activities according to SOPs and guidelines
• Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations
• Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting
• Maintaining a good working knowledge of the assigned Clinical studies for narratives
• Attending/conducting internal, drug safety and project specific training sessions
• Imparting trainings to the new starts during the induction sessions and the team as required.

Skills:

• Analytical and problem-solving skills
• Excellent interpersonal skills
• Excellent verbal / written communication skills
• Excellent organizational and prioritization skills
• Ability to work collaboratively and effectively in a team environment
• Client focused approach to work
• Ability to evaluate data and draw conclusions independently
• A flexible attitude with respect to work assignments and new learning
• Ability to negotiate on behalf of the department to ensure resources, timelines and expectations are aligned
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Fluency in written and spoken English
• Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
• Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.
• Provides departmental expertise and perspectives to promote prospective business opportunities.
• Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
• Typing and transcription accuracy

Knowledge and Experience:

• Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field.
• Good knowledge of medical terminologies

Education:

• Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)
• A degree in Medicine/Dentistry/Physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage