Mgr, Safety & PV - Gurgaon Office Based Full-time Job

Description

Manager, Safety & Pharmacovigilance

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE

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 committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 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.

Job responsibilities 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. Provides oversight and guidance on organizational goals and company objectives.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. o Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed. o Works with Finance to ensure appropriate customer invoicing, where required. o Approves project time cards and invoicing. o Provides sponsors with scheduled project updates and reports. o 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: o Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs) o Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan. o Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes. Participates in process development and improvement of departmental functions. o Works with Business Development to actively solicit new business, as needed. o 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. Participates in bid defense meetings. 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.Maintains understanding and ensures compliance of SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP modules, study plans and the drug development process.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 membersManaging resourcing's needs/issues and escalating to senior management as necessary.Participates in audits/inspections and ensures inspection readiness. Participates in quality investigations and implementation of corrective and preventive actions.Performs other work related duties as assigned.Minimal travel may be required. Qualifications

What we're looking for

7+ years of experience in ICSR Case Processor role 2+ Years of experience in Team Lead / Supervisor/Manager role Should have working experience in Workflow Management, Line Management, Performance Management, Client/Stakeholder management, Report, Quality/CAPA related activities Willing to work from office