Chandana Arra

Pharmacist with 12+ years in drug safety, quality and regulatory work across India and the UK, now based in New Jersey and available immediately. Seven years on a drug safety team covering QA, regulatory and pharmacovigilance for US and EU products in Oracle Argus, five years as a Superintendent Pharmacist (the UK equivalent of pharmacist-in-charge) alongside drug safety consulting, and earlier clinical-trial safety and case-processing experience in India.

Comfortable on both sides of drug safety: day-to-day ICSR case and aggregate reporting in the safety database, and the quality, SOP and inspection-readiness work that keeps a PV system audit-ready.

Drug Safety Consultant - Clinigen Pharma — via Vise Services Pvt Ltd - London, UK

(2021-06 - 2026-08)

• Booked in, quality-checked and initially assessed adverse event cases from suppliers via paper, email and fax, and monitored mailboxes and Argus ESM to ensure timely acceptance of reports.
• Accepted E2B cases through Argus ESM from European Health Authorities on behalf of country offices not online with Argus, and uploaded AE reports via Drop in Data Entry II on behalf of country offices that could not do so themselves.
• Performed safety-database data entry as needed and coded events and drugs correctly so cases were forwarded to the relevant Therapeutic Area Teams and Licensing Group.
• Applied US and EU pharmacovigilance requirements in day-to-day case handling, with monthly compliance tracking and CAPA follow-through for late cases.

Superintendent Pharmacist - UK community pharmacy group - via Vise Services Pvt Ltd - London, UK

(2016-09 - 2021-05)

• Held overall responsibility for clinical governance and professional standards across both pharmacies, in line with GPhC standards and MHRA requirements.
• Led GPhC inspections and internal audits as the main regulatory contact, kept sites inspection-ready, and followed gaps through to corrective and preventive action.
• Owned patient safety and regulatory reporting, including suspected adverse reactions to the MHRA through Yellow Card, and incident and near-miss reviews with the teams.
• Oversaw controlled-drugs governance: safe storage, register entries, regular reconciliation and audits, and investigation of discrepancies.
• Kept SOPs and governance policies current and reviewed workflows for safety and accuracy across around 20,000 prescription items a month.
• Led a team of around 40 — pharmacists, pre-registration trainees, technicians, dispensers, counter assistants, operations and IT staff — covering competency checks, training plans, CPD and supervision of pre-registration training.
• Handled MHRA drug alerts and recalls, from quarantining stock to contacting affected patients, and worked with operations and IT on governance for new services before go-live, including Pharmacy First, Covid and flu vaccination, and Weight Management.

Senior Regulatory Specialist - Cognizant - London, UK

(2011-06 - 2015-08)

• Supported pharmacovigilance and safety monitoring across assigned clinical trials, preparing and processing safety reports including IND Safety Reports, adverse events, reportable events and investigator notifications.
• Prepared and submitted required safety information to IRBs and coordinated safety documentation for Data Safety Monitoring Boards (DSMBs) and Medical Monitor review.
• Reviewed and supported updates to Investigator Brochures (IBs), reviewed safety information for impact across studies and protocols, and supported sponsor review of safety-related literature and public records.
• Provided safety oversight and training to study teams and research staff, including SIV training and other study-specific safety education, and maintained documentation and audit/inspection readiness.

Drug Safety Associate - Natco Pharma - Hyderabad, India

(2007-07 - 2009-09)

• Booked in, quality-checked and initially assessed adverse event cases, monitored Argus ESM and mailboxes for timely acceptance, and performed safety-database data entry.
• Coded events and drugs for correct forwarding to Therapeutic Area Teams and Licensing Group, and uploaded AE reports on behalf of country offices unable to do so themselves — foundational Argus / E2B case-processing experience.

Bachelor of Pharmacy - Osmania University, India (2007)

Master's - Pharmaceutical Chemistry - Biju Patnaik University, India

Overseas Pharmacist Assessment Program - University of Hertfordshire, UK