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Job Description
Quintiles is currently looking to recruit Safety Publication Professionals to work in a highly metric driven environment and be able to deliver quality documents within a stipulated timeframe.
The principal responsibilities will be:
· Review documents with excellent data cleaning/quality control skills
· Work in a highly metric driven environment and work to meet all metrics related to productivity, quality and turn around time.
· Ability to reprioritise work based on shifting business needs to meet report timelines
· Ability to interact/communicate with Aggregate Reports staff to address issues found during review and drive timely solutions
· Take personal accountability/responsibility for decisions and delivering results
· Evaluate/comprehend comments from reviewers of reports for appropriateness and respond accordingly
· Constantly (re)prioritise work to manage projects often requiring multitasking skills
· Participate in required training and related activities when required
· Ability to project manage and handle several tasks and prioritize work.
Resolve multiple stakeholders' comments and conflict resolution in finalizing documents.
· Keeps abreast of current data, trends, aggregate report writing/regulatory knowledge, developments and advances in area of drug development and Pharmacovigilance
Required Skills/Abilities:
· Quality orientation and attention to detail
· Ability to work independently and as part of a team
· Accountability and responsibility for delivery of results
· Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines
· Ability to follow standard operating procedures
· Excellent verbal and written communication skills (oral, formal, e-mail and teleconference); ability to communicate in a global environment: diplomatic
· Familiarity with good medical writing standards and guidelines like the AMA Manual of Style.
· Microsoft Word competence (tables, basic formatting)
· Global Safety-Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations)· · MS Excel skills
Education and experience requirements:
· Required: Bachelor's or Graduate degree in health, life sciences (Phar.D., MPharm, PhD, MPH, MBBS, and MD).
· Pharmaceutical industry experience would be preferred.
· Aggregate report writing experience required (PSURs, PADERs, ASR, SBR, INDs, and SUSARs)
· Awareness of Drug Safety Pharmacovigilance and/or Drug Safety Experience (case management, spontaneous, solicited and clinical cases).
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