Manager - Safety & PV (ICSR)

Syneos Health; India; On-site; INR 1,500,000 - 2,800,000; Full time

Job summary

Syneos Health in India seeks an experienced Pharmacovigilance leader to manage safety projects and a team of PV professionals. You will oversee study budgets, sponsor communications, and ensure compliance with SOPs and regulatory requirements.

The role requires 10+ years in pharmacovigilance, 5+ years in people management, and a biology-related degree. Strong Excel, SQL, Power BI skills are preferred. Moderate travel may be required.

Qualifications

• 10+ years of experience in pharmacovigilance.
• 5+ years of experience in people management.
• BA/BS in biological sciences or related field (or nursing) required.

Responsibilities

• Line management of staff including hiring, training, performance appraisals, and counseling.
• Oversee safety and pharmacovigilance projects and budgets with a focus on quality and compliance.
• Coordinate with internal departments to ensure timely safety reporting and document reviews.
• Mentor Safety team members and drive process improvements within Safety.

Skills

Leadership

Project management

Communication

Education

BA/BS in biological sciences

Tools

MS Excel

SQL

Power BI

ARGUS/ARISg

Job description

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 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 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