Covance Asst Drug Safety in Beijing, China
Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per Merck’s procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.
Responsible for aggregate safety report submissions in the country(ies) in accordance with Global Safety procedures and health authority requirements.
Responsible for the reconciliation of adverse events reports received from other Merck operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable
Responsible for the filing, storage and archiving of safety-related data in accordance with Merck’s policies and local requirements.
Responsible for being compliant with local PV regulations, Merck policies and procedures and Global Safety procedures at the country level.
Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.
Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.
Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope.
Complete and document required PV training within the required timelines.
Perform other activities as requested byline manager.
The incumbent must have a health, life science, or medical scince degree or equivalent by education / experience.
Prefer he/she has at a minimum 1year of pharmaceutical industry experience or CPA/CRA experience.ThePV Specialistisexpected to have strong communication and time management skills, and have the ability to work independently with minimal supervision.
Job Number 2018-18267
Job Category Clinical Operations
Position Type Full-Time
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