PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients.
Post: Scientist (Level II) - Bangalore-122132
Job Description:
To plan, co-ordinate and deliver, under supervision, components of the signal-detection services contracted to PPD.
To use PPD or client procedures (and other departmental tools or systems as required), current regulations and ICH/local guidelines regarding signal detection/safety surveillance, and scientific/clinical expert knowledge in order to establish and execute high-quality signal-detection activities in line with Client-specific and departmental objectives.
To participate in the development of new signal detection systems and processes as required.
Tracks signal-detection activities and metrics, and generates reports for compliance-review by senior signal detection staff as needed.
Obtains product-specific historical and existing safety documentation as directed by senior signal-detection staff and reviews these to draft Signal-Detection and Management Plans
Requirements:
- Bachelor's degree in Nursing, Medical Technology or Pharmacy with 2+ years of clinical experience
- Or Life Science degree with 2+ years of relevant industrial or clinical experience and 2+ years of pharmacovigilance experience
- Clear and detailed writing skills and analytical thinking for scientific literature review, pertinent data gathering, data synthesis, analysis and authoring aggregated data summaries
- Job holder should be able to apply company policy and procedure to resolve variety of issues whilst developing professional expertise
Preferences
- 3 years of pharmacovigilance
- Post-approval pharmacovigilance experience
- Experience of compilation and review of safety data and/or integration of safety data, including use of coding dictionaries
- Experience and understanding of proactive safety-management tools systems and mechanisms strategies
- Good knowledge of relevant pharmacovigilance regulations and applicable methodologies for data-analysis activities
- Good understanding of the drug-development drug-approval process within the ICH regions
Required Knowledge, Skills and Abilities:
· Sound computing skills
· Basic knowledge of other relevant disciplines (e.g. statistics, pharmacoepidemiology and associated methodologies) pertinent to assessing drug-utilization and safety at the population level
· Knowledge of medical and drug terminology, including coding dictionaries
· Skills to manage and co-ordinate tasks and projects with competing priorities
· Ability to work to a regulatory deadline
· Highly effective communication skills and use of English language
· Effective negotiating skills
Additional Information:
Experience: 3 Years
Location: Karnataka-Bengalaru
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Pharmacovigilance
Job Code: 122132
End Date: 15th May, 2015
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