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Opportunity to work as Senior Safety Specialist in INC Research - Pharmacist may apply

 

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Post: Senior Safety Specialist

Job Description
Performs all aspects of the collection, processing, and reporting of adverse events/endpoints adhering to all data protection guidelines, Health Insurance Portability and Accountability Act (HIPAA), Good Clinical Practices (GCPs), regulatory guidelines, and study procedures.    May lead or oversee one or several projects of various levels of complexity.  Manages daily workload of Safety Specialists within the department with limited line management responsibilities. Mentors and trains junior Safety Specialists.  Ensures that the project activities are completed in a timely manner with acceptable quality and acts as a decision maker.  Supports business development activities and delivers presentations.

Interfaces between Company, sponsors, vendors, and other departments in the area of safety and pharmacovigilance; assists in the design and implementation of safety collection, processing, and reporting systems; acts as a primary point of contact for information regarding assigned projects; represents Safety and Pharmacovigilance on cross functional teams.


Core Responsibilities
1. Assumes responsibilities of safety project leader/endpoint manager for projects which require a team of Safety Specialists, including but not limited to:
a) Assignment of resources and timelines; reorganization of daily workload based on priority
b) Decision making for the project.
c) Proactive communication to management new issues and suggested solutions; and reporting availability to take on new assignments.
d) Development and review of project proposals, budgets, agreements, invoices, financial measures, and performance metrics.
e) Preparation of a Safety Management Plan.
f) Coordination of workload /workflow and coordination of status reviews.
g) Review of project performance metrics (including quality parameters, monthly budget reports, and changes in scope).
h) Approval of invoices.

2. Manages systems for receipt and tracking adverse event (AE)/endpoint information.


3. Processes AEs/endpoints according to Standard Operating Procedures (SOPs), and project specific safety plan.

Skills & Attributes
BA/BS in Life Science or Registered Nurse/Pharmacist.

Moderate experience in Safety and Pharmacovigilance or clinical/clinical research experience or equivalent combination of education and experience.  Clinical Research Organization (CRO) experience with therapeutic specialties preferred. Knowledge of relevant international regulations/guidelines and strong understanding and usage of medical terminology preferred. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e-mail, and internet. Strong organizational, presentation, documentation, analytical, oral/ written (English), and interpersonal skills with strong judgment and tactful discretion appropriate to a professional medical setting. Ability to make effective decisions, manage multiple priorities, exhibit high degree of accuracy, and meet deadlines in a highly dynamic environment.  Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment.

Additional Information:
Qualification: Bachelors Degree
Industry Type: Pharma/ Biotech/Clinical Research
Job ID: 14907
Area of Interest: Drug Safety & Pharmacovigilanc - 3530
Location: Ahmedabad-Gandhinagar
End Date: 20th September, 2014

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