safety Physician
Pi Health Cancer Hospitalstirunelveli, tamil nadu, in14 hours ago
Job descriptionMedical degree (MBBS, MD, DO or equivalent) is required. Board certification in a relevant field (e.g., internal medicine, or subspecialties like immunology or oncology) is preferred. 5-10 or more years of relevant work experience in drug safety, in the biotech and / or pharmaceutical industry Experience in individual case safety reporting (clinical trial and post-marketing), aggregate reporting, signal detection, risk management planning, and regulatory inspections. Knowledge of regulatory guidelines (FDA, EMA, ICH, GCP) and safety reporting regulations (e.g., E2B, MedWatch, CIOMS). Proficiency in MedDRA coding and adverse event classification (e.g., CTCAE, DAIDS). Experience in handling serious adverse events (SAEs), signal detection, and risk management. Strong communication for interacting with study teams, investigators, partners and regulatory authorities. Must possess excellent oral and written English communication skills. Ability to prioritize across multiple complex clinical research studies Excellent written and verbal communication skills, with experience in medical writing and safety documentation. Strong analytical skills and problem-solving skills, with the ability to interpret and summarize complex safety. Experience with PV SOP development.
About the job
We are seeking a Safety Physician to join our growing Pharmacovigilance team. You will be responsible for the medical evaluation and oversight of safety data across clinical development programs, ensuring compliance with regulatory requirements. The ideal candidate will have a strong foundation in pharmacovigilance and clinical safety, and will be responsible for the analysis, coding, interpretation, and reporting of safety data. This position offers the opportunity to work at the intersection of clinical development, regulatory affairs, and medical safety, and includes collaboration with cross-functional teams and external partners.
Responsibilities
- Monitor participant safety during clinical trials by reviewing adverse events, SAEs, and providing medical assessments.
- Conduct medical review of individual case safety reports (ICSRs), including SAEs, ADRs, and SUSARs including assessment of causality, expectedness, and severity of adverse events.
- Perform aggregate safety data analysis and contribute to aggregate safety reports (e.g., DSURs, PSURs / PBRERs, RMPs) and safety narratives.
- Support safety-related regulatory submissions and responses (e.g., INDs, NDAs, BLAs).
- Ensure timely and accurate reporting of SAEs and safety signals to regulatory authorities.
- Review experimental protocols and informed consent documents; prepares, reviews, and edits presentations regarding safety review committee meetings.
- Assist in the preparation of new drug application safety updates, investigational new drug safety reports, investigator communication, product labelling / package inserts, and other reports as necessary.
- Provide medical expertise to clinical study teams, investigators, and safety personnel for safety-related queries and escalations.
- Support signal detection and safety review activities through data preparation, literature review, and maintenance of safety surveillance plans and risk management strategies.
- Analyse clinical trial safety data; present at Data Safety Monitoring Board (DSMB) meetings.
- Maintain / update agent-specific clinical and preclinical toxicity study summary tables for investigational agents.
- Develop and Implement Safety Management Plans.
- Communicate safety issues to internal stakeholders and regulatory agencies; represent PV in cross-functional teams.
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Safety • tirunelveli, tamil nadu, in