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Opportunity for Senior Pharmacovigilance Scientist in Quanticate

 

Clinical courses

Quanticate is the world’s largest Global Clinical Research Organization (CRO) specializing in the provision of data related services including: Clinical Data Management, Biostatistics and Clinical Programming, Medical Writing, Pharmacovigilance services, Remote monitoring approaches
For almost 20 years, we have supported pharmaceutical, biotechnology, nutritional and medical device companies in all phases of development and across many therapeutic areas. Our employees are our most important assets and we support them to offer the best in customer excellence and to enable them to provide value and expertise to our clients.

Post: Senior Pharmacovigilance Scientist

Job Description
The Quanticate Bangalore Office is looking to hire a Senior Pharmacovigilance Specialist to conduct ongoing pharmacovigilance activities, in addition to providing operational oversight to pharmacovigilance projects, and to ensure that projects are delivered efficiently and effectively, according to required Standard Operating Procedures, regulations, contracts and quality standards.

You will gain exposure to a broad range of clinical trial studies, working across Phases I-IV in a wide variety of therapeutic areas and working as part of local and global project teams.


Responsibilities:
Carry out ongoing pharmacovigilance operational activities for projects as required, including; case data entry, case assessment, coding, narrative writing, expedited reporting (including EudraVigilance), data reconciliation and literature review. Also, generation of safety reports and listings for ongoing safety data review and for inclusion in periodic reports, in addition to conducting signal detection activities
Perform ongoing quality control checks on case reports, listings and PV documents prior to submission or sending to other team members or client
Preparation and updating of project-specific Safety Plans, including defining local reporting requirements.  Also, writing or input into other project documents and processes, such as the Data Management Plan, Coding Conventions and Literature Search Strategy
Act as PV Operational Lead on assigned projects, providing oversight and ensuring that projects are set up and run according to all applicable regulations, guidelines, SOPs, quality standards and contracts, as well as to client requirements.  In addition, provide PV operational advice to customers and be their day-to-day contact for PV
Prepare for, and participate in, internal and client audits and follow-up of findings as appropriate
Assist the Head of Pharmacovigilance with system and process updates and improvements, including keeping abreast of local PV regulations that may affect reporting requirements for ongoing projects
Sign-off and approve of individual case safety reports
Determination of reporting requirements per case and subsequent reporting to Regulatory Authorities and other bodies as required
Sign-off and approval of line listings, reports and other deliverables

Candidate Profile


  • Substantial experience in all aspects of pharmacovigilance operations gained within the pharmaceutical or CRO industry, including case entry, narrative writing, coding, assessment, case follow-up, reporting, line listing generation, signal detection and literature review
  • Experienced in PV reporting (expedited and periodic), including the use of EudraVigilance for electronic reporting
  • Experience in oversight of PV projects and processes and preparing PV documentation, such as Safety Plans
  • Experience in case QC and mentoring of others
  • PV experience gained in a CRO, in a client-facing role
  • Pharmacy, life science or healthcare degree, minimum 2i
  • Excellent understanding of scientific and medical terminology
  • In depth knowledge of pharmacovigilance regulations and requirements
  • Proficient in the use of industry standard safety databases, including proficiency in the use of Oracle Argus as an end user
  • EudraVigilance trained and certified by the European Medicines Agency; proficient in the use of EudraVigilance and able to act as Responsible Person
  • Knowledgeable about global reporting requirements and able to continually keep up to date with these
  • Proficient in the use of standard Microsoft Office software packages, such as Word, Excel and PowerPoint
  • Excellent communication skills, both written and verbal
  • Strong attention to detail and the ability to perform accurate and complete QC
  • Advanced organisational and time management skills; able to prioritise, plan and execute tasks efficiently and effectively, adhering to strict timelines and feeding back any potential issues in a timely manner

Additional Information:
Location:
Bangalore
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: R&D
ID: 2015-1385
End Date: 3
1st March, 2015

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