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Job Title : Dir, Safety and Pharmacovigilance (India)
Req ID : 17003404
Directs the global Safety and Pharmacovigilance functions. Plans and directs the financial and operational performance and strategic planning of the business unit. Supervises all associates through the subordinate managers of the respective groups within Safety and Pharmacovigilance. Responsible for all aspects of collection, processing and reporting of Adverse Events (AEs), Serious Adverse Events (SAEs), and Suspected Unexpected Serious Adverse Reactions (SUSARs), delegated to the Company Safety and Pharmacovigilance department.
•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.
- 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.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.