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Mgr, Safety & Pv (Icsr- Office Based)

0-2 years
Not Disclosed
10 April 11, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science 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 - Office Based)

Updated:

Yesterday

Location:

India-Asia Pacific – IND-Hyderabad-Raheja-Mindspace, India

Job ID:

25002242-IND519

Company:

Syneos Health®


About Syneos Health:

Syneos Health® is a leading integrated biopharmaceutical solutions company that accelerates customer success by combining clinical, medical, and commercial insights. With a presence in 110 countries and 29,000 employees, Syneos emphasizes agility, innovation, and patient-centric solutions.


Why Work at Syneos Health:

  • Career development and progression

  • Supportive leadership and inclusive culture

  • Global diversity and Total Self culture

  • Employee recognition and rewards programs


Job Responsibilities:

Team & Project Management

  • Line management including hiring, transfers, training, terminations, and performance appraisals

  • Assign and monitor project workloads; guide team to meet goals and quality standards

  • Oversight of Safety & Pharmacovigilance (PV) projects

  • Ensure financial accountability: budget reviews, invoicing, and timecard approvals

  • Coordinate with cross-functional teams for timely safety reporting

Operational Excellence

  • Review and update departmental SOPs and Safety Management Plans

  • Improve processes for efficiency and compliance

  • Represent Safety & PV in project/client meetings

Business & Compliance

  • Support Business Development in client proposals and bid defenses

  • Review clinical safety documentation for consistency and compliance

  • Ensure regulatory compliance with SOPs, ICH GCP, GVP, and global regulations

Training & Quality

  • Identify and deliver training needs

  • Mentor team members and manage resourcing issues

  • Participate in audits, inspections, and implement CAPA as needed

Other

  • Perform additional duties as assigned

  • Minimal travel may be required


Qualifications:

  • Education: BA/BS in life sciences, healthcare, or nursing (or equivalent)

  • Experience: Demonstrated leadership, project management, and CRO experience preferred

  • Skills:

    • Financial and budget analysis understanding

    • Microsoft Office, Visio, Outlook, and document management tools

    • Strong communication, flexibility, and decision-making in dynamic environments


Additional Information:

This job description is not exhaustive and may be modified at the company’s discretion. Syneos Health is an equal opportunity employer and supports accommodations in line with ADA and other global legislations.a