About Us

ABOUT RADIKAN PHARM-MED

Physician-Led Pharmacovigilance and Drug Safety Consultancy

Radikan Pharm-Med Ltd. provides specialist pharmacovigilance physician consultancy services to pharmaceutical and biotechnology companies across the full product lifecycle—from First-in-Human studies and clinical development through regulatory submission, product launch and post-marketing use. Experience includes consulting on setting up and overseeing compassionate use programs, post-marketing registries and safety studies.

Our services combine strategic safety leadership with hands-on medical expertise in individual case assessment, safety surveillance, signal management, risk management, benefit–risk evaluation, and safety governance, compliance, and communication.

Extensive experience in authoring and reviewing safety documents, including PSUR, DSUR, RMP, IB, DCSI, ICF, CSR, CCDS, aRMM tools, Prescribing Information, Regulatory responses, and Submission documents.

Experience spans investigational and marketed products across oncology, immunology, infectious diseases, diabetes, cardiovascular medicine, and neurology.

Scalable Pharmacovigilance & Medical Safety Support

We provide flexible, scalable access to experienced pharmacovigilance physicians and safety scientists, working under senior medical oversight. Support can be tailored to specific projects, development programmes, individual products, or broader pharmacovigilance functions, allowing companies to expand safety capabilities as their needs evolve.<

Medical Safety Oversight

Medical review of ICSRs; SUSAR and AESI assessment; review of complex or medically significant cases; medical queries and follow-up; analysis of similar events; causality and expectedness assessment; and senior medical review and sign-off, as required.

Safety Surveillance & Signal Management

Routine and targeted safety surveillance; signal detection, validation, evaluation and management; participation in safety review meetings; assessment of emerging safety issues; preparation of signal evaluation reports; and development of medically supported regulatory and risk-management recommendations.

Clinical Development Safety

Safety input into clinical trial protocols, Investigator’s Brochures and informed consent forms; development and review of Safety Management Plans and eCRFs; SAE and SUSAR oversight; support for Data Monitoring Committees and adjudication committees; safety governance; and medical safety support to clinical development teams and medical monitors.

Aggregate & Regulatory Safety

Preparation and medical review of DSURs, PBRERs/PSURs and other aggregate safety reports; preparation of safety sections for regulatory submissions; responses to regulatory authority questions; safety input into product information and labelling; and assessment and implementation of safety-related regulatory variations.

Risk Management & Benefit-Risk

Development and maintenance of Risk Management Plans; preparation of safety specifications; identification and development of risk-minimisation measures; evaluation of risk-minimisation effectiveness; and ongoing benefit-risk assessment throughout clinical development and the product lifecycle.

Virtual Head of Drug Safety / Fractional Safety Physician

Senior pharmacovigilance and medical safety leadership for early-stage biotechnology and pharmaceutical companies that do not yet require a full-time Head or VP of Drug Safety or an internal pharmacovigilance department. Support can include safety strategy, governance, vendor oversight, regulatory preparedness, development of PV infrastructure, and senior medical oversight of outsourced or internal safety activities.