Drug Safety Physician

Job description

Accountabilities: Monitor and evaluate patient safety data during clinical trials, including adverse events and serious adverse events (SAEs), ensuring appropriate medical assessment and classification. Ensure timely reporting of safety data, signals, and regulatory submissions in compliance with global standards and regulatory authorities. Provide medical expertise to clinical study teams, investigators, and pharmacovigilance stakeholders on safety-related matters and escalations. Lead or support causality, severity, and expectedness assessments of adverse events across clinical programs. Contribute to risk management activities, including development and maintenance of risk management plans and REMS strategies. Prepare, review, and support safety documentation such as DSURs, PSURs, safety narratives, and regulatory safety reports. Participate in data safety monitoring boards (DSMBs), audits, and regulatory inspections, ensuring compliance of safety systems and databases. Conduct safety signal detection, literature review, and benefit-risk assessments to support ongoing clinical decision-making. Review clinical protocols, informed consent forms, and safety-related study documentation to ensure regulatory and ethical compliance. Develop and maintain safety management plans, medical monitoring plans, and toxicity summaries for investigational products. Requirements: Medical degree (MD, DO, or equivalent) is required. 5–10 years of experience in pharmacovigilance, clinical trials, or drug safety within the pharmaceutical or biotech industry. Strong knowledge of global regulatory guidelines including FDA, EMA, ICH, GCP, and safety reporting standards (E2B, MedWatch, CIOMS). Experience in adverse event coding and classification systems such as MedDRA, CTCAE, or DAIDS. Hands-on experience with safety surveillance activities, including SAEs, signal detection, and risk management. Clinical experience (minimum 2+ years), with exposure to specialties such as internal medicine, oncology, or infectious diseases considered a plus. Strong analytical skills with the ability to interpret complex clinical and safety data and translate it into actionable insights. Excellent written and verbal communication skills, including experience in medical writing and regulatory documentation. Ability to collaborate effectively with cross-functional teams, investigators, and regulatory authorities in a global environment. Experience in mentoring or training junior staff is an advantage. Benefits: Competitive compensation package aligned with experience and industry standards. Comprehensive health and wellness coverage including medical support programs. Opportunity to work on global clinical trials and innovative therapeutic areas. Professional development and continuous learning opportunities in pharmacovigilance and clinical research. Exposure to regulatory inspections, global submissions, and high-impact safety decision-making. Collaborative and scientifically driven work environment. Career growth opportunities within clinical safety and drug development functions. Flexible work arrangements depending on project and organizational needs. How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1 This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Drug Safety Physician in India. This role is a highly specialized clinical safety position focused on protecting patient wellbeing throughout the lifecycle of clinical trials and investigational products. You will act as a key medical authority for safety surveillance, ensuring adverse events are properly assessed, documented, and reported in compliance with global regulatory standards. Working closely with clinical, regulatory, and pharmacovigilance teams, you will evaluate safety signals, support risk management strategies, and contribute to benefit-risk assessments for investigational therapies. The position plays a critical role in ensuring the integrity of clinical research by guiding safety decisions and ensuring regulatory compliance across studies. You will also support the development of key safety documentation used in global submissions and regulatory inspections. In a collaborative and highly regulated environment, you will interface with investigators, data monitoring boards, and internal stakeholders. This is an impactful opportunity for a medically trained professional passionate about drug safety and clinical research excellence.