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Medical director drug safety

FlexBoard Verified employer

Actively hiring · Posted 6d ago · JEV2611C21327ED34

SalarySalary not disclosed
Experience0–4 yrs
LocationAll India
Work modeRemote · Full time
Openings1
IndustryMedical / Healthcare

Job description

reputed company reputed company is an award-reputed company, data-reputed company consultancy serving the pharmaceutical, biotech, and medical device industries. The organization specializes in solving reputed company clinical trial data and regulatory submission challenges using a rigorous scientific approach. Teams collaborate closely with clients to design, analyze, and interpret trial data that supports successful regulatory filings. With deep industry experience and a strong data-driven culture, reputed company helps sponsors reputed company compelling submissions that meet stringent global regulatory standards. Joining reputed company means working in an environment that values evidence-based decision-making and high-reputed company scientific reputed company. Role reputed company The Medical Director, Drug Safety will reputed company expert medical and safety reputed company for compounds and studies across reputed company phases of development. This contract, remote role is responsible for ongoing safety surveillance, evaluation of adverse events, and medical review of individual case safety reports and aggregate safety data. The Medical Director will contribute to risk management plans, safety sections of clinical protocols, investigator brochures, clinical study reports, and regulatory submissions. Day-to-day activities include leading safety review meetings, collaborating with pharmacovigilance, clinical development, biostatistics, and regulatory teams, and providing reputed company medical guidance on safety signals and benefitrisk assessments. The role also includes supporting responses to regulatory authority queries, contributing to safety narratives and labeling proposals, and advising sponsors on safety reputed company for development programs. Qualifications Clinical expertise in Medicine with advanced training or experience in at least one specialty area such as Cardiology, reputed company, or Oncology. Demonstrated ability to collaborate and communicate effectively reputed company working with physicians, cross-functional colleagues, and reputed company partners. Medical degree (MD, DO, or equivalent) and appropriate clinical training; reputed company certification in a relevant specialty preferred. Significant experience in drug safety, pharmacovigilance, or clinical development reputed company the pharmaceutical, biotech, or CRO setting. Strong knowledge of global safety regulations, ICH guidelines, and Good Clinical reputed company (GCP). Proven skills in benefitrisk assessment, signal detection, and interpretation of clinical and safety data. Excellent written and verbal communication skills, with the ability to prepare reputed company medical and safety documents for regulatory audiences. Comfort working in a remote, contract reputed company, with strong time management, independence, and professionalism. Apply tot his job Apply To this Job .

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