- Support the Pharmacovigilance team in collecting, tracking, and processing Adverse Events (AEs) from all sources with accuracy and efficiency.
- Independently triage AEs to determine reportability in compliance with regulatory guidelines and clinical assessment standards.
- Code AEs using MedDRA and WHODRUG, applying clinical judgment to ensure correct categorization.
- Conduct quality control checks on case data to ensure accuracy, consistency, and completeness in safety databases and regulatory reporting forms (e.g., MedWatch, CIOMS I).
- Ensure timely submission of expedited case reports to regulatory authorities in compliance with global regulations.
- Draft concise and clinically sound AE narratives following established guidelines.
- Formulate and communicate follow-up queries to clients or stakeholders for additional case information.
- Assist in the preparation of aggregate reports and regulatory documentation as required.
- Work collaboratively with PV management, project managers, and internal teams to meet deadlines and project goals.
- Lead and mentor junior staff, including Drug Safety Associates and Drug Safety Coordinators, in case processing.
- Participate in the regular reconciliation of Serious Adverse Events (SAEs) between drug safety and clinical trial databases.
- Gain deep knowledge of client products and therapeutic areas.
- Contribute to the creation and maintenance of SOPs, work instructions, and other pharmacovigilance documentation.
- Stay current with evolving drug safety regulations and contribute to ongoing process improvements within the team.
- Bachelor's degree in a life sciences discipline (e.g., Pharmacy, Nursing) is preferred.
- Minimum of 5 years of experience in pharmacovigilance, including at least 3 years in drug safety.
- Broad knowledge of domestic and international regulations, including ICH and FDA guidelines.
- Strong understanding of the drug development process and AE reporting requirements.
- Proficient in MedDRA and WHODRUG coding.
- Familiar with FDA and international AE reporting regulations.
- High attention to detail and ability to manage complex data accurately.
- Excellent written and verbal communication skills, especially in crafting clear narratives.
- Strong time management and multitasking abilities.
- Proficiency in Microsoft Office and safety database software.
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Job Description · Job Type: · Full Time Remote · 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, ...
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Manage and review expeditable adverse events, product quality complaints and medical information to the required standard and submit them to the client and the regulatory agencies (if required) within the agreed/stated timelines. · Assist in the conduct of process review for assi ...
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Senior Drug Safety - Pune - Thepharmadaily
Description
Key Responsibilities
Case Management and Reporting
Regulatory Compliance and Documentation
Collaboration and Leadership
Continuous Improvement and Development
Qualifications
Education
Experience
Skills
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Senior Drug Safety
Only for registered members Pune
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Drug Safety Specialist
Only for registered members Pune, Maharashtra
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Drug Safety Assessment Professional
Only for registered members Pune
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PV Drug Safety Professional
Only for registered members Pune
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Safety Systems Consultant
Full time Only for registered members Pune
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Safety Systems Consultant
Only for registered members Pune, Maharashtra
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Pharmacy Incharge
Only for registered members Pune
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Safety & PV Specialist II
Only for registered members Pune
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Staff Nurse
Full time confidential- Pune
-
Functional Quality Specialist I
Full time Thepharmadaily- Pune
-
Mechanical Engineer
Full time Only for registered members Pune
-
Safety & PV Specialist l (QC Experience)
Only for registered members Pune, Maharashtra
-
Functional Quality Specialist I
Full time Thepharmadaily- Pune
-
Functional Quality Specialist I
Only for registered members Pune
-
Production-Executives & Shift In Charge
Full time confidential- Pune
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Medical Contact Center Associate II
Only for registered members Pune, Maharashtra
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Pharmacist
Full time confidential- Pune
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Pharmacist
Only for registered members Pune, Maharashtra
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Clinical Data Associate
Only for registered members Pune
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Pharmacovigilance Operations Lead
Only for registered members Pune, MH, India
