Instagram
youtube
Facebook

Manager, Safety & Pharmacovigilance (Icsr)

5-8 years years
not specified
10 Sept. 5, 2025
Job Description
Job Type: Hybrid Education: BA/BS in Biological Sciences, Natural Science, Healthcare field, Nursing, or equivalent combination of education and experience. Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title

Manager, Safety & Pharmacovigilance (ICSR)


Company

Syneos Health®
Location: Hyderabad, India (Hybrid Work Model)
Job ID: 25100465
Updated: August 14, 2025


About Syneos Health

Syneos Health is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success by delivering innovative clinical, medical affairs, and commercial solutions. With a workforce of 29,000 employees across 110 countries, Syneos Health fosters a culture of collaboration, agility, and inclusion.


Position Summary

The Manager, Safety & Pharmacovigilance (ICSR) is responsible for leading and managing the Safety & Pharmacovigilance team focused on Individual Case Safety Report (ICSR) processing. This role includes line management, project oversight, process improvement, compliance, budget management, and cross-functional coordination.


Key Responsibilities

People Management

  • Manage and lead Safety & Pharmacovigilance team members including hiring, transfers, performance appraisals, training, and counseling.

  • Approve time sheets and manage employee utilization.

  • Provide guidance on administrative policies, technical issues, and prioritization.

  • Mentor team members and support professional development.

Project & Quality Management

  • Assign and review project workloads and ensure adherence to Safety Management Plans.

  • Monitor quality and efficiency of team deliverables.

  • Manage Safety and Pharmacovigilance projects ensuring contractual and budget compliance.

  • Review study budgets, coordinate with Finance for invoicing, and approve project expenses and time cards.

  • Provide regular project updates to sponsors.

  • Coordinate cross-departmental safety reporting and issue resolution.

Departmental Leadership

  • Assist in developing, reviewing, and approving departmental SOPs.

  • Review and ensure execution of Safety Management and Reporting Plans.

  • Recommend and implement process improvements to enhance efficiency and effectiveness.

  • Collaborate with Business Development to support new business opportunities.

  • Represent Safety & Pharmacovigilance at project and client meetings.

Regulatory & Compliance

  • Review and approve safety sections in project proposals, protocols, and case report forms (CRFs).

  • Ensure compliance with SOPs, Work Instructions, GCP, ICH guidelines, GVP modules, and drug development processes.

  • Manage audit and inspection readiness and participate in investigations and CAPA implementation.

Training & Development

  • Identify training needs and deliver relevant safety training to team members and other departments.

  • Support mentoring and ongoing development of the Safety team.

Other

  • Manage resource needs and escalate issues to senior management as needed.

  • Perform other duties as assigned.

  • Minimal travel may be required.


Qualifications

Education

  • BA/BS in Biological Sciences, Natural Science, Healthcare field, Nursing, or equivalent combination of education and experience.

Experience

  • Minimum 8+ years in Pharmacovigilance.

  • At least 5 years of people management experience.

Technical Skills

  • Proficiency in MS Excel is essential.

  • Experience with ARGUS / ARISg Safety Databases preferred.

  • Knowledge of SQL and Power BI is a plus.

  • Experience in Clinical Research Organization (CRO) with therapeutic specialties preferred.

  • Understanding of financial budgets and analysis tools is beneficial.

  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint), Visio, Outlook, TeamShare (or similar).

Soft Skills

  • Excellent oral, written, and interpersonal communication skills.

  • Strong graphic presentation skills.

  • Ability to build effective client and team relationships.

  • Flexibility and adaptability in a dynamic, matrixed work environment.

  • Strong decision-making and multitasking abilities.


Employment Details

  • Location: Hyderabad (Office-based, Hybrid work model)

  • Job Type: Full-time


Why Syneos Health?

  • Commitment to career development and progression.

  • Supportive management and inclusive culture promoting authenticity.

  • Collaborative, innovative, and global work environment.


Additional Information

  • Job duties may change at company discretion.

  • Equivalent experience and education may be considered.

  • The company complies with labor laws and promotes equal opportunity employment.

  • Reasonable accommodations are provided as per ADA guidelines.


Application

Interested candidates can apply directly or join the Syneos Health Talent Network for future opportunities.

Learn more: Syneos Health Website