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Sr Specialist / Expert / Sr Expert - Safety Medical Writer

A career at our company is an ongoing journey of discovery: our 57,000 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.

Position Title -Sr Specialist / Expert / Sr Expert - 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.
  • Author 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.
  • Author responses to Health Authorities queries (ad-hoc queries, queries following submission of PBRER/PSUR, such as PRAC inquiries, etc.).
  • 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.
  • Review (both self- and peer) of SMW deliverables for data accuracy, consistency, 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 (5 to 8 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 signal management, benefit-risk assessment, literature surveillance 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:  With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com

 

Job Requisition ID:  211407
Location:  Bangalore
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Medical, Pharmacovigilance, Healthcare

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