Project Manager, Patient Safety

5+ years

Not Disclosed

Bengaluru

10 March 19, 2025

Job Description

Job Type: Full Time 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: Global Pharmacovigilance Operations Manager
Company: Fortrea, a Global Contract Research Organization (CRO)
Location: [Insert Location]

Job Overview:

Fortrea is seeking a Global Pharmacovigilance Operations Manager to oversee the management of safety data and adverse event (AE) reporting for clinical trials and post-marketing products. The role involves leading the global or regional pharmacovigilance operations, ensuring compliance with international regulations, and providing quality service to both internal and external clients. The post holder will manage expedited adverse event processing, provide safety data analysis, and maintain oversight of safety reporting for regulatory submissions, ensuring timely and accurate deliverables.

Key Responsibilities:

Pharmacovigilance Leadership:
- Lead and manage global or regional pharmacovigilance operations for assigned projects, ensuring all workflows are compliant with international safety regulations, SOPs, and safety guidelines.
- Provide oversight and ensure timely and accurate reporting of adverse events (AEs) and Serious Adverse Events (SAEs) to regulatory authorities, clients, and ethics committees.
- Review and approve patient narratives, adverse event coding using MedDRA, and the expectedness/listedness of adverse events.
- Monitor and manage the entry, tracking, and processing of safety data on adverse event databases.
- Ensure appropriate medical review for all adverse events and expedite reporting to regulatory agencies as required.
Project and Client Management:
- Collaborate with clinical operations, project management, and client teams to ensure adherence to regulatory requirements and client expectations.
- Lead client meetings, providing project updates and addressing any concerns related to pharmacovigilance activities.
- Prepare and participate in audits (client or regulatory), ensuring compliance with safety regulations and internal processes.
Signal Detection and Data Review:
- Lead signal detection and perform trend and pattern analysis to identify potential safety concerns.
- Review cumulative safety data for submission to DSMBs, regulatory authorities, or clients.
- Manage safety databases and ensure consistency across systems for accurate reporting.
Training and Mentorship:
- Provide training on safety reporting and pharmacovigilance processes to project teams, investigators, and clients.
- Mentor junior team members and ensure the consistent application of safety procedures across projects.
- Cascade relevant information from internal and external meetings to the pharmacovigilance team.
Regulatory Compliance and Reporting:
- Prepare and ensure the timely delivery of pharmacovigilance reports, including ICSRs for SAEs and aggregate safety reports.
- Oversee the preparation of Safety Management Plans (SMPs) and reconciliation plans for assigned projects.
- Contribute to the development of clinical trial protocols, case report forms, and adverse event reporting forms.
Operational Oversight:
- Monitor project timelines and budgets, ensuring efficient management of resources and financials.
- Identify potential scope changes or budget overruns and address issues promptly with the client.
- Ensure routine quality reviews of adverse event reports and aggregate reports to meet regulatory compliance standards.

Qualifications (Minimum Required):

Education:
- A degree in Biological Sciences, Pharmacy, Nursing, Life Sciences, Chemistry, or a related field is preferred.
- Relevant work experience may be considered in lieu of formal education.
Experience:
- 8-12 years of experience in pharmacovigilance or adverse event reporting, with a strong understanding of global safety regulations.
- Experience in managing adverse event reports, regulatory submissions, and safety data analysis.
- Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, and pharmacovigilance regulations.
- Experience leading and mentoring teams in pharmacovigilance and project management.
- Proficient in using safety databases and medical coding systems (e.g., MedDRA).
Skills:
- Excellent communication, leadership, and organizational skills.
- Ability to anticipate and address problems proactively.
- Strong knowledge of pharmacovigilance practices and regulatory compliance.
- Financially intuitive with the ability to manage project budgets.

Preferred Qualifications:

EudraVigilance Certification is a plus.
Knowledge of Medical Device Reporting is desirable.

Physical Demands/Work Environment:

Office environment.
Travel required (10-15%) including overnight stays, depending on project needs.

Fortrea is an Equal Opportunity Employer:

Fortrea is committed to diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We encourage all individuals to apply, regardless of race, religion, gender, national origin, sexual orientation, gender identity, disability, or other protected status.

For more information about how we collect and store your personal data, please refer to our Privacy Statement.

If you require reasonable accommodation due to a disability to complete your job application, pre-employment testing, or interview process, please contact: taaccommodationsrequest@fortrea.com. This email is only for job seekers requesting accommodations.

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Project Manager, Patient Safety

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