Cs Writing Scientist

1 month ago

Hyderabad, India Haleon Full time

**Job Description**:
**Site Name**: India - Andra Pradesh - Hyderabad

**Posted Date**: Jan 25 2023

Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating. And a culture that’s uniquely ours. Care to join us. It isn’t a question

Are you energized by a highly visible safety role that ensures the accuracy of critical safety data? If so, this Safety Pharmacovigilance Manager role could be an ideal opportunity to explore.

As a Safety Pharmacovigilance Manager, you will be responsible for ensuring local regulatory obligations for clinical safety reports are met. This includes the appropriate collection, processing and reporting of adverse events (AEs) for GSK marketed and investigational products.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
- ACCOUNTABILITIES/RESPONSIBILITIES
- Prepare safety writing deliverables, including planning, authoring, contributing to safety strategy and data analysis, coordination with contributing functions, and quality control of assigned safety writing projects from initiation to completion.
- Maintain product safety information at active level and ensure consistent use across regulatory reports.
- Use appropriate sources of information and database searches to retrieve relevant data for inclusion to safety reports
- Review published literature for identifications of safety signals and/or inclusion into periodic reports.
- Serve as the principal owner and co-ordinator of the safety deliverables and have responsibility for completion of the deliverable in compliance with Company guidelines.
- Produce or contribute to safety documentation for regulatory submissions and to fulfil legal obligations of the MAH. Examples include but are not limited to Safety Risk Management Plans, Periodic Benefit Risk Evaluation Reports, Developmental Safety Update Reports, Medical Device Periodic Safety Update Reports, Cosmetic Undesirable Effects Reports, Canadian Annual Reports, US Periodic Adverse Drug Experience Reports, and Clinical Overviews and Summaries.
- Provide safety summaries in support of communication on relevant safety information both, internally and externally.
- Assist CS Science team in producing regulatory supporting documentation for labelling updates and in performing routine signal detection activities (e.g. review of ICSRs)
- Accountable for maintaining personal readiness in response to internal audit or regulatory inspection
- With guidance, contribute to process improvement initiatives within Consumer Safety

**_ Why You?_**:
**Basic Qualifications & Experience**:
We are looking for professionals with these required skills to achieve our goals:

- Degree in Biomedical or Healthcare-related specialty
- Experience with Good Clinical Practices (GCCP), clinical safety documentation and reporting of adverse events from clinical trials
- Experience with local regulatory requirements and pharmacovigilance methodology
- Experience working with the principles of data collection, manipulation and retrieval
- Minimum 8 years of experience with at least 6 years of writing experience in Pharmacovigilance preferred.

**Preferred Qualifications**:
If you have the following characteristics, it would be a plus:

- ** COMPETENCIES AND SKILLS**:

- Fluency in English and solid writing/editorial skills
- Prior experience authoring clinical, safety or regulatory documents (e.g. PBRERs)
- Sound knowledge of MedDRA terminology and familiarity with medical terminology
- Ability to prioritize and manage multiple demands and projects within deadline
- Good presentation skills, and ability to interpret and present data in a logical manner
- Self-starter, flexible in adapting to changing circumstances or new information, able to adapt quickly in a fast-moving environment.
- Sound computing skills

**_ Why Haleon?_**:

- Our values and expectations_**_ _**_are at the heart of everything we do and form an important part of our culture._
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Continuously looking for opportunities to learn, build skills and share learning.
- Sustaining energy and well-being
- Building strong relationships and collaboration, honest and open conversations.
- Budgeting and cost-consciousness

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding

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