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Associate Medical Safety Director

9.00 to 12.00 Years   Chennai, Noida, Hyderabad, Kolkata   01 Jul, 2022
Job LocationChennai, Noida, Hyderabad, Kolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryIT - Software
Functional AreaPharmacist / Medical Representative
EmploymentTypeFull-time

Job Description

    Dear candidate ,We are hiring for Associate medical safety officer Work Experience Required : 9+YearsLocations : HybridAs a global safety officer, provides PV expertise for assigned products, maintains PV expertise, andunderstanding of international safety regulations and guidelines. Provides and maintains PV and riskmanagement expertise to internal and external customers. Maintains knowledge of product, theirenvironment and recent literature. Communicates and represents PV data evaluation, interpretationand summary or conclusions as relevant. Responsible for signal detection and analysis. as well asreview, preparation, and/or contribution to responses to questions from health authorities, ethicscommittees, Internal Review Boards (IRBs), external partners. Manages product safety alerts, asneeded. Responsible for Identifying and implementing proactive safety analysis strategies to furtherdefine the safety profile of the product. Provides proactive risk assessment. Responsible fordocumenting, coordinating, reviewing and validating periodic reports, e.g.: RMP update, IND AnnualReport, Annual Safety Report/Development Safety Update Report, Periodic Safety Update Report,Health Hazard Evaluation etc., leads the preparation of clinical overview to support labelling changesand oversees the safety part of the Company Core Safety Information (CCSI/CCDS) creation/update. Prepares for and particpates in the SMC and SMT meetings and also provides inputs duringlabellling working group meetings. Participates and provides inputs for audit related activities(internal and external partners). Prepare the List of safety concerns/ list of safety topics for aproduct based on the existing RSI and properties of the product.RegardsHR

Keyskills :
pharmacovigilancemedical affairs

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