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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