ResponsibilitiesGeneral Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee Interacting with internal and external stakeholders for resolving issues under guidance of senior physicians. Attending and/ or presenting at client/cross functional meetings along with other stakeholders under guidance of senior physicians. Developing knowledge of global regulatory requirements and reporting obligations Case report medical review (as applicable) Performing medical review of cases not limited to (including non-serious and serious spontaneous (including legal cases), clinical trial, and literature cases including combination products {drug-device) according to established client/Parexel Standard Operating Procedures (SOPs; as applicable) and liaising with the client under supervision Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality Review appropriateness of medical content in narrative for medical coherence Assessing seriousness, listedness / expectedness of reported events. Providing medical inputs to case processing team Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional) Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative Identify and resolve case issues, coordinate with client therapeutic/legal team under supervisionQualification & Experience    Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical SchoolCompletion of at least basic training in clinical medicine (residency, internship etc.)Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date Ability to work within defined procedures and practices to determine appropriate action Developing knowledge of drug safety, clinical trial and pharmacovigilance principles Good presentation and verbal/written communication skills. Demonstrates potential for technical proficiency, scientific creativity, and collaboration Computer proficiency, ability to work with web-based applications and familiarity with the Windows operating system and Microsoft Office apps. A flexible attitude with respect to work assignments and new learnings. Good understanding of international drug regulation including ICH GCP, GVP, and all other applicable regulations and guidelines. Knowledge and Experience: Experience in pharmacovigilance and medical data review activities is desirable but not essential Good knowledge/understanding of medical terminology. Fresher/ relevant experience in pharmacovigilance/ Drug Safety/clinical practice.

ResponsibilitiesCompilation and update of drug dossiers with focus on the clinical part in close alignment with the therapy field director Provide answers to authorities on registration related medical/pharmacological questions in close alignment with the director of the respective therapy field and with drug regulatory Support of drug development projects Participation in audits: support of therapy field leader with respect to therapy field relevant documents Supportive function in risk management, in particular concerning medico-regulatory topics: Provide support in the development, maintenance and updating of documents related to risk management deliverables Participation in cross-functional teams for medical-regulatory aspects Authorship of assessments concerning product development issues, in analysis of clinical data and in defining the medical evidence needed for driving or improving product development processes in close collaboration with the therapy field director Planning and support of medico-scientific activities related to generation of clinical evidence (studies) in close alignment with the respective director and Clinical Research Assessment of potentially relevant Literature within the frame of the literature vigilance processQualification & ExperienceUniversity degree in Medicine, Pharmacy, natural science, medical engineering or related science EXPERIENCE AND REQUIRED SKILLS: At least 5 years of Regulatory Medical writing work experience, preferably in a comparable position within health care or pharmaceutic or medical technology companies or research institutions Knowledge of relevant regulations for drugs Competence in the direct compilation of medical and scientific documents, and in the coordination and collection of contributions from various people/departments Experience in conducting systemic and process-oriented searches in medical and scientific databases