• Developing Pharmacovigilance plans for planned or ongoing clinical studies.
• Managing safety reporting activities outsourced to CROs or other service providers.
• Working closely with project and study teams to ensure that PV needs are addressed.
• Maintaining a comprehensive safety signaling program for delegated the products.
• Developing, implementing, and maintaining pre- and post-approval product-specific risk management plans.
• Assisting with the development and critical review of various product documents (e.g., investigator brochures, protocols, core data sheets).
• Participating in the development and monitoring of registry or epidemiologic studies associated with approved products.
• Serving as product safety expert on assigned teams (e.g., product labeling committees).
• Performing medical review of individual case safety reports; • Analyzing aggregate safety data for periodic report (e.g., PSUR) preparation, internal clinical safety review, and preparation of ad hoc reports such as regulatory authority response documents.
• Tracking and trending safety issues being monitored and maintaining appropriate documentation of activities and findings.
• Formulating and implementing SOPs, process flow maps, and other quality documents.
Qualifications :
• MD degree with clinical practice experience (primary care or internal medicine subspecialty preferred).
• Excellent interpersonal skills and communication skills, including oral presentation and technical manuscript writing.
• Competence with technology applications including commercial safety databases.
• Ability to work effectively as an individual contributor and as project team member; collaborative spirit.
• Thorough understanding of the regulatory environment for Pharmacovigilance, with working knowledge of worldwide regulations and guidelines.
• Ability to understand and apply biostatistics and epidemiology methodology
