Expert Safety Medical Writer

2 days ago

Bengaluru, India Merck KGaA Darmstadt Germany Full time

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

PositionSafety Medical Writer

Job Location - Electronic City - Bangalore

**Your Role**:

- Support Global Patient Safety (GPS) Safety Scientists and Safety Strategy Leads with regards to safety medical writing (SMW) activities.
- Assist senior staff in developing sections ofa wide range of pharmacovigilance documents including but not limited to various Periodic Safety Reports, Signal Evaluation Reports, Safety Strategy and Core Benefit-Risk Documents, Risk-Management Plans, Patient Safety Narratives and Health Hazard Reports.
- Responsible for proofreading, building and populating tables anddrafting appendices.
- Produce high quality, accurate and fit-for purpose documents with clear conclusions.
- Effectively and clearly communicate technical, medical, and scientific information in critical submission and internal PV documents in order to deliver high quality reports within the specified timelines.
- Performs quality control of SMW deliverables for data accuracy, consistency, editing, and ensuring alignment with the processes, templates and regulations.
- Participate in meetings related to key PV activities.
- Collaborate cross functionally for continuous improvement of standards and best practices for medical writing

**Who youare**:

- Graduate degree or equivalent job experience with comprehensive pharmacovigilance knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
- Excellent written and spoken English (including medical terminology) with a familiarity with AMA style guide.
- Profound pharmacovigilance experience (3to 5years' experience in drug/patient safety) required.
- Demonstrated experience in Periodic Safety Reports of interpretation & presentation of aggregate safety data.
- Strong knowledge of regulations and guidelines (FDA, EMA, ICH, EU GVP, etc.).
- Experience in working in electronic document management systems (EDMS), signal management andbenefit-risk assessment is beneficial.
- Proven experience in ability to consistently produce documents of high quality and express complex data in a concise and easy-to-read way.
- Comprehensive experience in working in cross-functional, global teams, across different regions and time zones.
- A flexible attitude with respect to work assignments and new learning; readily adapts to changes.

**What we offer**: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life

Job Requisition ID: 256577

Location: Bangalore

Career Level: D - Professional (4-9 years)

Working time model: full-time

**North America Disclosure**

**Notice on Fraudulent Job Offers**
Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information.

**Job Segment**:R&D, Pharmacovigilance, Document Management, Medical, Oncology, Research, Healthcare, Technology

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