PPD is seeking an experienced Senior Drug Safety Physician to join our growing Pharmacovigilance & Safety Services team in Hyderabad. The ideal candidate will bring strong clinical expertise, deep understanding of global safety regulations, and the ability to provide high-quality medical oversight across safety operations.

? Key Responsibilities
Provide medical review, assessment, and approval of adverse event (AE) / serious adverse event (SAE) reports.
Ensure medical accuracy, clinical relevance, and regulatory compliance for all safety deliverables.
Perform causality assessment, seriousness evaluation, and clinical review of cases.

? Required Qualifications
MBBS / MD degree (preferably in a clinical specialty).
3–6+ years of experience in pharmacovigilance, drug safety, or clinical research.
Strong understanding of ICH-GCP, FDA, EMA, and global PV regulations.

? Preferred Skills
Exposure to signal management, safety database systems (e.g., Argus, ArisG).
Ability to manage timelines in a fast-paced, global environment.
Strong medical writing and documentation expertise.

Specializes in medication management and drug interactions in clinical settings. Works with healthcare teams to optimize drug therapies, monitors patient responses to medications, and provides education on drug use. Reviews patient records, advises on dosage and administration, and ensures the safe and effective use of pharmaceuticals in patient care.

Assists in managing and monitoring clinical trial budgets, including tracking expenses and ensuring financial compliance. Requires knowledge of budgeting and strong analytical skills.

Supports quality assurance activities, including conducting inspections, testing products, and ensuring compliance with GMP. Requires knowledge of quality control procedures and strong attention to detail.

Oversees the planning, implementation, and monitoring of clinical trials. Manages budgets, timelines, and ensures compliance with clinical trial protocols and regulations. Requires experience in clinical trial management, strong leadership skills, and the ability to work with cross-functional teams.