Expert Safety Medical Writer

1 week ago

Bengaluru, India Merck KGaA Darmstadt Germany Full time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimageable with us.

Position Safety 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 of a 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 and drafting 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 you are**:

- 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 (3 to 5 years' 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 and benefit-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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

  • Expert Safety Medical Writer

    3 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...

  • Comw-0, Expert Safety Medical Writer

    2 weeks 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...

  • Drug Safety Medical Expert

    9 hours ago

    Bengaluru, India Biocon Biologics Full time

    Job DescriptionDrug Safety PhysicianAt Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural...

  • Senior Medical Writer, Safety Reports

    1 week ago

    Bengaluru, India Theron Solutions Full time

    Job Insights:Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety teamResponsibilities:Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.Responsible for end-to-end...

  • Subject Matter Expert(Medical device)

    1 week ago

    Bengaluru, Karnataka, India Celegence Systems Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    ROLE : Senior Subject Matter Expert(Medical Device)Experience : 8-12 yearsJob location: Jayanagar(Hybrid)Core Requirements1. Regulatory Expertise and Document QualityDeep knowledge of Medical Device Regulations: You must be proficient in specific medical device regulations, primarily MEDDEV 2.7/1 Revision 4 and the EU Medical Device Regulation...

  • Senior Medical Writer

    1 week ago

    Bengaluru, Karnataka, India IQVIA Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Senior Medical Writer IQVIA is looking for candidates who have expertise in regulatory writing to join our Real World Evidence team. The Ideal candidate will have 5-12 years of experience working as Regulatory Medical Writer, adept in developing and authoring clinical study protocols, informed consent documents, clinical study reports. ...

  • Senior/Expert Scientific Writer

    4 weeks ago

    Bengaluru, India Merck Sharp Dohme Msd Full time

    Job Description - Working both independently and alongside other team members to develop medical content for a range of project types, audiences and writing styles including, but not limited to, medical communication content (including publications and congress materials) and medical education content - Actively contribute to improvement initiatives across...

  • Medical Safety Advisor

    1 week ago

    Bengaluru, Karnataka, India IQVIA Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Senior Medical Safety Advisor Job Overview The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as...

  • Senior Medical Safety Advisor

    6 days ago

    Bengaluru, Karnataka, India IQVIA Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Senior Medical safety advisor Job Overview The objective of this position is to provide medical expertise in the evaluation of safety data from a variety of sources as part of the overall pharmacovigilance process and determine the medical and scientific relevance of serious adverse event reports within the context of the product's safety profile as...

  • Senior Medical Writer

    1 week ago

    Bengaluru, Karnataka, India Primevigilance Full time ₹ 1,20,000 - ₹ 1,80,000 per year

    Company DescriptionWe are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...