Manager - Safety & PV (ICSR)

5264 Syneos Health India Private Limited; Hyderabad; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Syneos Health is seeking a Manager - Safety & PV (ICSR) in Hyderabad, India. The role leads pharmacovigilance and safety activities, manages a team, and ensures adherence to safety reporting standards. Strong PV background with leadership and project management is essential to drive departmental objectives.

The position emphasizes oversight of Safety and Pharmacovigilance operations, client communications, and continuous process improvements within a global CRO framework.

Qualifications

• Minimum 10+ years in pharmacovigilance.
• 5+ years in people management.
• BA/BS in biological sciences or nursing or related field.

Responsibilities

• Line management including transfers, hiring, development, and performance appraisals.
• Oversee Safety and Pharmacovigilance projects and budgets.
• Provide SOPs and Safety Management Plan oversight.
• Coordinate with internal departments for safety reporting and client communications.
• Monitor team performance and ensure quality of outputs.

Skills

Leadership

People management

Pharmacovigilance

Communication

Project management

Education

B.A./B.S. in biological sciences or nursing

Tools

ARGUS/ARISg Safety Databases

SQL

Power BI

MS Excel

Job description

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. Every day we perform better because of how we work together, as one team, each the best at what we do. 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®. 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.
  • Reviews study budgets and expenses; ensures all study related contractual and budgeting issues are upheld and performed.
  • Works with Finance to ensure appropriate customer invoicing, where required.
  • 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:
  • Assists in the development, review, and approval of departmental Standard Operating Procedures (SOPs)
  • Reviews, provides input, and ensures the execution of the Safety Management Plan/Safety Reporting Plan.
  • Evaluates processes for potential improvement in efficiency and effectiveness and recommends changes.
  • Participates in process development and improvement of departmental functions.
  • Works with Business Development to actively solicit new business, as needed.
  • Represents Safety and Pharmacovigilance or ensures 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 members
• Managing 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.

What we’re looking for

• 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
• 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, 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

Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment. Learn more about Syneos Health. http://www.syneoshealth.com

Additional Information 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. 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.

We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world. Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.