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Manager, Safety & Pharmacovigilance (Icsr)

8+ years
₹20,00,000 – ₹30,00,000
10 Aug. 19, 2025
Job Description
Job Type: Full Time Education: BA/BS 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

Manager, Safety & Pharmacovigilance (ICSR)
Location: Hyderabad, India (Hybrid)
Job Type: Full Time

About the Company:
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success through clinical, medical, and commercial expertise. With over 29,000 employees across 110 countries, the company partners with clients to deliver innovative solutions, streamline operations, and accelerate the delivery of new therapies.

Job Summary:
The Manager, Safety & Pharmacovigilance (ICSR) is responsible for overseeing pharmacovigilance operations, managing teams, ensuring compliance with safety reporting requirements, and driving departmental improvements. The role involves direct line management, project oversight, process optimization, client interaction, and ensuring regulatory adherence.

Key Responsibilities:

  • Manage line operations including hiring, training, transfers, performance appraisals, terminations, and professional development.

  • Assign and review project work, ensuring alignment with organizational goals.

  • Monitor team performance, ensuring quality and efficiency per project scope and safety plans.

  • Provide oversight for safety and pharmacovigilance projects, including:

    • Reviewing budgets and expenses, coordinating with Finance for invoicing.

    • Approving project time cards and sponsor invoicing.

    • Providing regular project updates to sponsors.

    • Coordinating with internal departments for timely safety submissions and issue resolution.

  • Support departmental management through:

    • Development, review, and approval of SOPs.

    • Reviewing and ensuring execution of Safety Management Plans.

    • Identifying and implementing process improvements.

    • Participating in business development and bid defense activities.

  • Review and approve safety portions of proposals, study protocols, and CRFs.

  • Mentor and train team members, ensuring regulatory compliance and inspection readiness.

  • Manage resourcing needs, escalate issues as required, and participate in audits and quality investigations.

  • Perform other related duties and minimal travel as required.

Qualifications & Experience:

  • Bachelor’s or Master’s degree in Biological Sciences, Nursing, or related field.

  • Minimum 8 years of pharmacovigilance experience, with at least 5 years in people management.

  • Strong project management and leadership skills.

  • Experience in Clinical Research Organization (CRO) settings preferred.

  • Proficiency in ARGUS or ARISg safety databases; SQL and Power BI knowledge preferred.

  • Excellent MS Excel skills and strong command of Microsoft Office Suite (Word, PowerPoint, Visio, Outlook).

  • Strong oral, written, and interpersonal communication skills with ability to present data effectively.

  • Ability to manage multiple priorities, adapt to change, and work independently in a matrix environment.

  • Financial and budget management experience preferred.

Salary Range: ₹20,00,000 – ₹30,00,000 per annum (estimated, based on senior pharmacovigilance manager roles in India).