Manager, Safety & PV

Syneos Health, Inc.; Tlalnepantla; Presencial; MXN 806,000 - 1,166,000; Jornada completa

Descripción de la vacante

A leading biopharmaceutical solutions organization based in Tlalnepantla is seeking a Safety Management professional to oversee Safety team members and ensure compliance with regulatory guidelines. The ideal candidate will possess a degree in biological sciences or a related field, along with project management skills. Responsibilities include managing budgets, overseeing Safety services, and participating in process development. The position requires strong leadership and interpersonal skills within a dynamic environment.

Formación

• Bachelor's degree in biological sciences, nursing, or equivalent.
• Progressive responsibility with leadership and project management experience.
• Clinical Research Organization experience preferred.

Responsabilidades

• Manage Safety team members for Safety services.
• Ensure compliance with regulatory guidelines.
• Review study budgets and expenses.

Conocimientos

Leadership skills

Project management

Interpersonal communication

Research organization experience

Microsoft Office proficiency

Educación

BA/BS in biological sciences or related field

Herramientas

Microsoft Office Suite

Visio

Descripción del empleo

Updated: December 15, 2025
Location: Tlalnepantla, MEX, Mexico
Job ID:25102863

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.

Our Clinical Development model places the customer and the patient at the center of everything we do. We continuously seek ways to simplify and streamline our work, making Syneos Health easier to collaborate with and 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 about changing lives.

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 culture 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. By bringing together diversity of thoughts, backgrounds, cultures, and perspectives, we create a place where everyone feels they belong.

Job Responsibilities

Line‑management responsibilities include 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.
• Works with Finance to ensure appropriate customer invoicing, where required.
• Approves project time cards and invoicing.
• Provides sponsors with scheduled project updates and reports.
• Coordinates 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.
• 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 ensure consistency 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.
• Is responsible for the identification, preparation, and delivery of any necessary training to Safety team members and other Syneos Health departments or groups. Mentors Safety team members.
• Manages resourcing needs/issues and escalates 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.

Qualification Requirements

• BA/BS in the biological sciences or related disciplines in the natural science/health care field, nursing degree, or equivalent combination of education and experience.
• Progressive responsibility with demonstrated leadership skills and project management experience.
• 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, PowerPoint), Visio, email (Outlook), TeamShare (or other shared 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.

Additional Information / Legal Notice

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 an 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.

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 in a highly competitive and ever‑changing environment. Learn more about Syneos Health at www.syneoshealth.com.

Summary

Manages Safety team members responsible for all Safety services while adhering to data protection guidelines, HIPAA, GCPs, regulatory guidelines, GVP, and study procedures. Participates in process development, budget reviews, and project management. Ensures consistency and communication between the Safety team members and management.