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PPD Pharmaceutical development I Pvt Ltd. Mumbai : SAFETY SPECIALIST
Website: http://www.ppdi.com
Keywords: SAE, Pharmacovigilance
Designation: SAFETY SPECIALIST
Experience: 2 – 5 Years
Location: Mumbai
Education:
UG – B.Pharma – Pharmacy,B.Sc – Any Specialization
PG – M.Pharma – Pharmacy,M.Sc – Any Specialization
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Healthcare, Medical, R&D
Posted Date: 27 Apr
Job Description:
The Safety Specialist is responsible for the receipt and follow-up of serious adverse events (SAEs) and the
input of data into the safety database(s). He/she must maintain knowledge and understanding of PPD’s SOPs and
WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety
issues; and effectively interface with project teams, client company, and investigators regarding SAE activities. The
Safety Specialist may also get involved in the preparation of department SOPs and WPDs. He/she also
prepares for, and attends audits.
Desired Candidate Profile:
Familiar working with SOPs and WPDs
General awareness of ICH-GCP, Clinical Trial Directives, regulatory documents and safety issues
Capable of undertaking primary safety specialist role for specific projects.
Ability to prioritise workload effectively
Ability to work within team environment but also independently with supervision
Basic knowledge of working with databases
Good knowledge of MS Office (including Word, Excel and PowerPoint
Good oral and written communication skills
Ability to present SAE processes at investigator / sponsor meetings
Company Profile:
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
Executive Name: Vikrant Dongre
Address:
Not Mentioned
Telephone: +91-22-42472963
No Comment Received
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