pharmacovigilance openings in quintiles

Opening with Quintiles !!
Safety Publication professionals with 1 to 5 years of experience

RESPONSIBILITIES:

· Ability to deliver quality documents within the stipulated timeframe.
· Self and peer review documents with excellent data cleaning/quality control skills
· Worked in a highly metric driven environment and has worked 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
· Good understanding of common statistical methods and interpretation of their results.
Qualifications

REQUIRED KNOWLEDGE, SKILLS AND 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 and guidelines relating to pharmacovigilance).
· Windows OS familiarity/manoeuvrability
· MS Excel skills

EDUCATION & EXPERIENCE REQUIRED:

· Required: Bachelor's or Post Graduate degree in Health & Life Sciences (Phar.D., MPharm, PhD, MPH, MBBS, and MD).
· 1 to 2 years of pharmaceutical industry experience would be preferred.
· Minimum of 1 year Aggregate Report Writing experience (PSURs, PADERs, ASR, SBR, INDs, and SUSARs)
· Awareness of Drug Safety Pharmacovigilance and/or Drug Safety Experience (case management, spontaneous, solicited and clinical cases). Familiarity with common safety databases is ideal.
Primary Location: IND-Karnataka-Bangalore