Safety Reporting Specialist – Pharmacovigilance (Fully Remote, India)
Job ID: R-01335773
Job Type: Full Time
Category: Clinical Research / Pharmacovigilance / Drug Safety
Work Mode: Fully Remote
Location: Bangalore, Karnataka, India
Work Schedule: Monday to Friday (Standard Business Hours)
About the Role
We are looking for a Safety Reporting Specialist to join a global Clinical Research Services organization supporting large-scale pharmacovigilance and safety reporting operations. This role plays a key part in ensuring accurate, compliant, and timely submission of safety reports in accordance with global regulatory requirements and country-specific legislation.
As a Safety Reporting Specialist, you will act as a primary safety contact on assigned projects, lead safety reporting activities, mentor junior team members, and collaborate closely with cross-functional stakeholders to maintain inspection-ready safety processes.
Key Responsibilities
Receive, prepare, review, and submit safety reports to relevant regulatory authorities, ethics committees, and internal stakeholders.
Ensure all safety reports are compliant with global and local regulatory timelines and legislative requirements.
Lead large-scale safety reporting projects, ensuring deliverables align with agreed processes and timelines.
Monitor compliance metrics and proactively identify risks related to reporting timelines or quality.
Provide input into the development, review, and enhancement of program-level and departmental SOPs and procedural documents.
Actively contribute ideas for process improvement and support implementation initiatives.
Liaise with cross-functional departments to coordinate safety reporting activities and attend internal and client meetings as required.
Provide guidance, feedback, and mentorship to junior team members and new hires.
Generate safety metrics and contribute to financial or project tracking activities where applicable.
Business and Stakeholder Engagement
Serve as a primary departmental contact for assigned projects.
Collaborate with internal and external stakeholders on complex safety-related matters.
Coordinate activities across functional areas to support seamless project execution.
Build and maintain professional relationships with senior internal and external stakeholders within the pharmacovigilance domain.
Required Knowledge, Skills, and Competencies
Excellent understanding of medical terminology and drug safety concepts.
Strong knowledge of global safety reporting requirements and regulatory frameworks.
Proficiency in Microsoft Office applications with a solid understanding of database systems.
Thorough familiarity with safety-related procedural documents and compliance standards.
Strong time management and multitasking capabilities in a deadline-driven environment.
Exceptional attention to detail and commitment to data quality.
Ability to influence and communicate effectively at all organizational levels.
Demonstrated initiative, negotiation, and problem-solving skills.
Strong analytical and critical-thinking abilities.
Proven ability to support and guide junior colleagues in safety reporting activities.
Ability to work effectively in a collaborative, global team environment.
Education and Experience Requirements
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biotechnology, or a related discipline (or equivalent qualification).
Minimum 2+ years of experience in safety reporting, pharmacovigilance, or clinical research within a CRO or pharmaceutical organization.
Hands-on experience with global safety reporting processes is required; exposure to multi-country submissions is preferred.
Why Join Us
Be part of a global clinical research organization committed to advancing patient safety and public health.
Work on international clinical programs with exposure to global pharmacovigilance operations.
Develop expertise in regulatory-compliant safety reporting within a structured, inspection-ready environment.
Access continuous learning, mentorship, and career development opportunities in drug safety and clinical research.
Collaborate with experienced professionals in a supportive, quality-driven culture.
Gujarat :
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