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 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