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Manager, Safety & Pharmacovigilance

5-8 years
Not Disclosed
10 Sept. 11, 2025
Job Description
Job Type: Hybrid Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ Life Sciences 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)

About Syneos Health

At Syneos Health®, we put patients and customers at the center of everything we do. Our clinical development model is designed to simplify and streamline work, making us easier to work with—and easier to work for. With 29,000 employees across 110 countries, we’re united by a passion for accelerating the delivery of therapies to change lives.

Work Here Matters Everywhere.


Why Join Us

  • Career development and progression opportunities.

  • Supportive and engaged leadership.

  • Technical and therapeutic area training.

  • Peer recognition and total rewards program.

  • A Total Self Culture where authenticity, diversity, and inclusion are valued.


Key Responsibilities

Leadership & People Management

  • Lead direct reports, including hiring, training, transfers, utilization, terminations, performance reviews, and professional development.

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

  • Monitor team performance, efficiency, and quality of deliverables.

  • Mentor and train Safety team members; ensure resourcing needs are managed/escalated as necessary.

Project Management & Oversight

  • Manage Safety & Pharmacovigilance projects as primary services.

  • Oversee study budgets, expenses, invoicing, and contractual deliverables.

  • Provide sponsors with scheduled project updates and reports.

  • Coordinate with cross-functional teams to ensure timely review and submission of safety reports and resolution of issues.

  • Approve project-related time cards, financials, and invoicing.

Process & Compliance

  • Develop, review, and approve departmental SOPs.

  • Ensure execution of Safety Management Plans/Safety Reporting Plans.

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

  • Maintain compliance with SOPs, WIs, global regulations, ICH, GCP, GVP modules, and study plans.

  • Ensure inspection readiness and participate in audits/inspections, CAPAs, and quality investigations.

Business Development & Representation

  • Partner with Business Development to support new opportunities.

  • Contribute to project proposals and bid defense meetings.

  • Review safety-related protocol sections, CRFs, and budget projections.

  • Represent Safety & Pharmacovigilance in project team meetings and client meetings.


Qualifications

  • Experience:

    • 8+ years in Pharmacovigilance.

    • 5+ years in People Management.

    • CRO experience with therapeutic specialties (preferred).

  • Education:

    • BA/BS in Biological Sciences, Nursing, or related discipline (or equivalent experience).

  • Technical Skills:

    • Strong MS Excel skills.

    • Experience with ARGUS/ARISg Safety Databases (preferred).

    • Knowledge of SQL / Power BI (desirable).

    • Proficiency in MS Office Suite, Visio, Outlook, and collaboration tools.

  • Other Skills:

    • Leadership and project management abilities.

    • Strong oral, written, and interpersonal communication skills.

    • Ability to manage multiple priorities and make effective decisions in dynamic environments.

    • Knowledge of budgets and financial analysis tools (preferred).


Additional Information

  • Minimal travel may be required.

  • Responsibilities and tasks listed are not exhaustive and may change based on business needs.

  • Syneos Health is committed to diversity, inclusion, equal opportunity, and reasonable accommodations under applicable laws.


About Syneos Health (Quick Facts)

  • Supported 94% of FDA novel drug approvals in the past 5 years.

  • Partnered on 95% of EMA authorized products.

  • Conducted 200+ studies across 73,000 sites and 675,000+ trial patients.


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