About Syneos Health:
Syneos Health ® (Nasdaq: SYNH) is the only biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically integrating clinical development, medical affairs and commercial capabilities to address modern market realities.
We bring together approximately 28,000 minds, across more than 110 countries, with a deep understanding of patient and physician behaviours and market dynamics. Together we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients.
Syneos Health supports a diverse, equitable and inclusive culture that cares for colleagues, customers, patients, communities and the environment.
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About Syneos Health Jobs In India:
Director, Safety and PV
Location: India-Asia Pacific – IND-Pune-Yerwada-Jail-Rd, India
Job ID: 22011953-IND745
Director, 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 a 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 a diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
• Oversees financial performance of assigned units; develops and manages top and bottom-line revenue growth and expense budgets for Safety and Pharmacovigilance.
• Provides operational and strategic leadership for Safety and Pharmacovigilance to achieve the Company’s mission, creating value for customers.
• Evaluates and measure performance metrics and improve processes, as needed.
• Directs the 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. Is accountable for appropriate escalation and resolution of issues within the department/business unit.
• Supports business development on project proposals and approval of Safety and Pharmacovigilance budgets.
• 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 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.
• Participates in the development, review, and approval of departmental Standard Operating Procedures (SOPs).
• Evaluates processes for potential improvement in efficiency and effectiveness and recommend changes.
• Participates, defines and approves process development and improvement of departmental functions and technology.
• Represents Safety and Pharmacovigilance or ensures Safety representation at project team meetings and client meetings.
• Provides oversight and governance between the Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance.
• Maintains understanding and ensures compliance with Standard Operating Procedures (SOPs), Work Instructions (WIs), global drug/biologic/device regulations, Good Clinical Practices (GCPs), ICH guidelines, Good Pharmacovigilance Practice (GVP) modules, study plans and the drug development process.
• Participates in audits/inspections and ensures inspection readiness.
• Participates in quality investigations and ensures implementation of corrective and preventive actions.
• Performs other work-related duties as assigned.
• Moderate travel may be required.
What we’re looking for
- Must be a Graduate. Highly preferred from any of MBBS, MDS, BAMS/BHMS/M. Pham qualification background
- Should have 15+ Years of working experience in Pharmacovigilance related activities
- Should have Strong Working experience in leading multiple PV projects at the global level
- Should have extensive working experience in Budget/Finance, Costing, Negotiations, RFP and RFQ
- Should have extensive working experience in Project Management, Line Management, Stakeholder and client Management at a global capacity
- Should have extensive working experience in RMP, Quality/CAPA, Audit related activities
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, MS Project), email, and the internet.
- Excellent oral, written, and interpersonal communication skills with strong graphic presentation skills.
- Ability to establish effective relationships with clients as well as team members.
- Ability to be flexible, adapt to change and 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.
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