Career in Safety and Pharmacovigilance at INC research

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INC research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I - Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women’s health trials. Our Trusted Process® methodology and therapeutic foresight leads our customers to more confident, better-informed drug and device development decisions.

Post : Dir, Safety and Pharmacovigilance

Job Description
• Oversees financial performance of assigned units; develops and manages top and bottom line revenue growth and expense budgets for drug safety and pharmacovigilance. 
• Provides strategic leadership for drug safety and pharmacovigilance to achieve the Company’s mission, creating value for customers. 
• Evaluates and measures performance metrics and improves processes, as needed. 
• Directs the drug safety and pharmacovigilance associates to achieve on-time quality customer deliverables, contractual project requirements, utilization goals, and profitable results. 
• Identifies and develops associates to carry out required functions.  Provides professional development and growth opportunities as appropriate. 
• Supports business development on project proposals.  Assists in the creation, development and nurturing of key strategic customer relationships; develops strong relationships with current and prospective customers to generate new and/or add-on business.     
• Effectively leads and encourages collaboration and work sharing between offices to create a unified global safety and pharmacovigilance team.  Ensures best practices and processes are followed globally. 
• Maintains current professional knowledge and expertise in fields of drug safety and pharmacovigilance to serve as a basis for providing “value added” expanded company services to all appropriate customers. 
• Line management responsibilities for associates.  Approves course of action on salary administration, interviews, hiring, terminations, professional development, performance appraisals, job descriptions and training. 
• Implements quantifiable performance standards to facilitate improvement of global efficiencies and operational excellence. 
• Maintains understanding of Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, and the drug development process.

 

Candidate Profile

  • BA/BS in biological sciences or related disciplines in the natural science / health care field/ life sciences.  Extensive clinical research experience including drug safety and/or pharmacovigilance experience or an equivalent combination of education and experience.  Significant line management experience.
  • Contract Research Organization (CRO) or pharmaceutical/biotechnology experience preferred.
  • Extensive in-depth knowledge of global and local regulatory requirements; strong understanding and usage of medical terminology.
  • Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project), email, and internet.
  • Effective organizational, presentation, documentation, analytical, oral, written, and interpersonal skills with strong judgment and tactful discretion.
  • Ability to make effective decisions and manage multiple priorities to meet deadlines in a highly dynamic environment.

Additional Information:
Location: Gurgaon
Education: B.Pharm, B.Sc, other
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Safety and Pharmacovigilance
Job ID:
17003404

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