Assoc Director Global Medical Safety Op Phys

Associate Director, Global Medical Safety Operations Physician. About ClinChoice ClinChoice is a clinical CRO dedicated to offering high-quality full development service to biopharmaceutical, medical device, and consumer products clients. Our services include clinical operations, project management, biostatistics, data management, regulatory affairs, medical affairs, and pharmacovigilance. ClinChoice has established major offices across US, China, Europe, India, Japan, and the Philippines with over 2,400 employees globally. POSITION SUMMARY: The objective of this position is to provide medical expertise regarding the operational aspects of individual case medical review. The Associate Director, Global Medical Safety Operations Physician (GMSOP) has primary responsibility for determining the medical and scientific relevance of adverse event reports within the context of the product's safety profile as well as other products within the same therapeutic area. These responsibilities include spontaneous reports, clinical and non-clinical studies, literature reports and other sources of safety data. Responsibilities Medical Review Non-Suspected Unexpected Serious Adverse Reaction (SUSAR) clinical trial cases for products in development Non-med significant Follow-up SUSARs Partner SUSARs (where is Company does not change the Business Partner assessment) SUSARs for non-company sponsored trials Spontaneous/ solicited individual case safety reports for products as assigned Perform aggregate review of non-serious cases in line listings Evaluate Individual Case Safety Report (ICSRs) for potential product quality issues (including device malfunctions, if applicable). Watchlist Targeted Follow-up Questionnaires Investigator Brochure activities as assigned Anticipated Events activities as assigned All other operational activities that require physician input example: Standard Operating Procedures (SOPs), CAPAs Periodic Adverse Drug Experience Reports (PADERs) WORKING RELATIONSHIPS/INTERFACES: Medical Safety Officers - frequent. Discuss findings from ICSR review/Analysis of Similar Events (AOSE)/Designated Medical Events (DME) and/or systematic surveillance program and suggest potential safety issues for further evaluation. Provide surveillance consultation on ad hoc safety issues and queries. Participate with Medical Safety Officers on preparation of Pharmacovigilance Plans or Risk Management Plans. Aggregate Reports Group - occasional. Discuss signal detection findings and suggest potential safety issues for discussion in Periodic Benefit-Risk Evaluation Report (PBRER) and other regulatory reports. Suggest potential search and analysis strategies for case series of interests. Support Desk - occasional. Suggest potential search strategy to identify case series of interests. Safety Associates - frequent. Reviews the Adverse Event (AE) reports prepared by the Safety associates and amends as needed. Requests specific follow-up information on cases. Ensures that the Safety associates are kept informed of product-specific information, such as labeling changes, new protocols, or potential safety signals. Safety Surveillance Physician (SSP) - frequent. Ensure bi-directional flow of product-specific information via participation in extended therapeutic team meetings, product-specific meetings, AOSE summaries, ad-hoc emails/telecons. Methods and Analysis - frequent. Ongoing evaluation of systems, tools and methodologies for aggregate data analysis and signal detection. GMSOP Team Lead - frequent. Ongoing discussions of ICSRs, performance and development as well as other work-related issues. Required Skills: A Physician (MD or equivalent), is required. A Board Certification (if US) is preferred. A minimum of 3 years of experience in industry, academia or patient care settings is required. Direct experience in pharmacovigilance is strongly preferred A minimum of 2 years in clinical practice after postgraduate training program is preferred. Sound knowledge of general medicine and clinical practice, and the ability to assess the clinical relevance of medical data and to interpret its clinical meaning is required. Experience and knowledge of Good Clinical Practices is required. Knowledge of pharmacovigilance regulatory requirements in US, the EU and globally is strongly preferred. Good communication skills (written and verbal) and the ability to work in a team-oriented, matrix environment is required. Significant experience and judgment required to identify and evaluate issues likely to be relevant in understanding safety profiles of a large product portfolio is required. ClinChoice is an Equal Opportunity Employer / Committed to Diversity