Gopal Kamgar
Patient Safety / Pharmacovigilance professional with experience in case triage, ICSR/ADR reporting, MedDRA coding, narrative writing, quality review, and follow-up across global PV workflows (FDA/EMA/ICH-GCP). Skilled in patient counseling, gathering missing adverse event information through inbound/outbound communication, and supporting drug safety decision-making. Strong pharmacology foundation with a focus on GLP-1 therapy education and drug information, including counseling to improve adherence and mitigate adverse effects. Experienced in regulated documentation and high-volume safety operations using Argus/ArisG.
Experienced healthcare professional prepared to excel in role. Skilled in risk assessment, regulatory compliance, and patient care standards. Strong focus on team collaboration and achieving results, with adaptability to changing needs. Expertise in data analysis, problem-solving, and fostering culture of safety and continuous improvement.
Experienced with patient safety protocols and risk management strategies. Utilizes analytical skills and effective communication to enhance patient care. Track record of improving incident reporting systems and fostering collaboration within healthcare teams.
Work History
Patient Safety Specialist
2 Years 6 Months- Provide patient counseling for specialty therapies, with emphasis on GLP-1 medication education, including dosing adherence, expected effects, and management of common adverse effects.
- Support ADR/AE reporting workflows by capturing and documenting safety information from patients and coordinating escalation when needed.
- Perform patient follow-ups to collect missing adverse event details (onset, severity, outcome, concomitant meds, relevant history).
- Conduct GLP-1 drug information support to answer patient inquiries regarding side effects, safety precautions, missed doses, and when to contact providers.
- Assist in ensuring accurate and complete safety reporting following SOPs and applicable compliance standards.
- Maintain timely documentation for safety cases and communicate effectively with internal teams and relevant healthcare professionals.
Associate Safety Specialist
1 Year 9 Months- Identified ICSRs and technical product complaints; forwarded to internal stakeholders within defined timelines.
- Conducted adverse event (SAE/AE) triage across multiple sources (LAM entry, EMA download, MHPD, XML import, mailbox).
- Entered cases into Argus Safety Database, performed quality review for consistency, accuracy, and compliance.
- Coded adverse event terms and product complaints using MedDRA and authored concise case narratives.
- Conducted follow-up calls with reporters/HCPs/patients to obtain missing information and update case status.
- Ensured compliance with SOPs, FDA/EMA requirements, and ICH-GCP; authored minor quality events and submitted to QA.
- Collaborated with teams and communicated professionally with adverse event reporters and client contacts.
- Supported senior team members in drug safety training activities.
Clinical Pharmacist
1 Year- Reported and documented adverse drug reactions and product issues to regulatory authorities.
- Provided clinical support to oncology patients, including monitoring chemotherapy regimens and safety.
- Monitored drug interactions to prevent medication errors and promote rational therapy use.
- Supported audits and participated in clinical safety evaluations for adverse event documentation.
- Delivered patient counseling focused on chemotherapy-related adverse effects and medication safety; educated patients on managing side effects and interactions.
Education
M.S. - Pharmacology & Toxicology
- Relevant Coursework: Pharmacogenomics, Autonomous Pharmacology, Advanced Pharmacology, Pharmaceutical Formulations
- GPA: 3.3
Pharm-D
- Affiliated to Jawaharlal Nehru Technological University, Hyderabad
- GPA: 69.3
Skills
PROFESSIONAL DEVELOPMENT
- Clinical Pharmacist Internship — General Medicine, General Surgery, Nephrology, Oncology & Orthopedics
- Hyderabad, India (1 year)
- Participated in ward rounds, collected medical histories, educated patients through verbal counseling
- Supported drug information queries, identified adverse drug reactions, and discussed interventions