Vacancy description
Syneos Health
India, Rāniganj
HSE-Safety Manager in Rāniganj, India is listed on Jobeax. Browse 30,000+ vacancies available.
Manager - Safety & PV (ICSR)
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.
Why Syneos Health
We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.
Line management responsibilities including transfers, hiring, utilization, terminations, training, professional development, performance appraisals, time sheet approval, and employee counseling. Advises staff on administrative policies and procedures, technical problems, and prioritization.
Assigns project work and reviews workload for all direct reports. Monitors quality of work and efficiency of team members with contracted scope of work and Safety Management Plan. Discusses below-target project goals with senior safety management.
Manages projects where Safety and Pharmacovigilance are the primary services.
ensures all study related contractual and budgeting issues are upheld and performed.
Approves project time cards and invoicing.
Provides sponsors with scheduled project updates and reports.
Coordinate with other internal departments and Safety functional areas to ensure timely review and submission of reports and documents relating to safety reporting as well as resolution of issues.
Participates in the management of the Safety and Pharmacovigilance department with the following actions:
Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan.
Represents Safety and Pharmacovigilance or ensure Safety representation at project team meetings and client meetings.
Reviews, advises, and approves Safety portions of project proposals to ensure wording adequately reflects the scope of work for Safety and Pharmacovigilance. Reviews clinical safety sections of study protocols and Case Report Forms (CRFs) to make sure information is consistent with the Serious Adverse Event form. Approves budget projections for the project.
Responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentor Safety team members
Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions.
Minimal travel may be required.
Should have minimum 10+ years of experience in pharmacovigilance and 5+ year's experience in People Management
BA/BS in the biological sciences or related disciplines in the natural science/health care field or nursing degree or equivalent combination of education and experience
Excellent MS Excel skills
ARGUS / ARISg Safety Databases are preferred
SQL / Power BI knowledge is good to have
Progressive responsibility with demonstrated leadership skills and project management
Clinical Research Organization (CRO) experience with therapeutic specialties preferred
Working knowledge of financial budgets and various financial analysis tools preferred
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace), and internet
Ability to be flexible, adapt to change, work independently, as well as part of a team in a matrix environment
Ability to make effective decisions and manage multiple priorities while delivering high quality work in a dynamic environment
We are always excited to connect with great talent. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.
Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. 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. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Why Syneos Health We are passionate about developing our people, through career development and progression; technical and therapeutic area training; peer recognition and total rewards program. We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we're able to create a place where everyone feels like they belong.
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