Job title: Consumer Safety Writing Scientist
Company: GlaxoSmithKline Pte Ltd
Job description: Job Description : Site Name: India – Andra Pradesh – Hyderabad Posted Date: Feb 9 2022 Key Responsibilities: Assist Consumer Safety product specialist in the continued safety monitoring and evaluation of their assigned GSK products in clinical devel
Job Description : Site Name: India – Andra Pradesh – Hyderabad Posted Date: Feb 9 2022 Key Responsibilities: Assist Consumer Safety product specialist in the continued safety monitoring and evaluation of their assigned GSK products in clinical development and/or the post-marketing setting Assist Consumer Safety product specialists in ensuring that adverse event and other safety information is efficiently evaluated and that safety reports are completed accurately and in a timely manner to meet global compliance and regulatory requirements Contributes to/assists in the production of deliverables and in other activities under direction of Consumer Safety scientists or physicians. Responsible for complete documents for non-complex activities or products. Deliverables/activities may include, but are not limited to: Periodic reports, risk management plans or reviews of safety data: Cosmetic UERs (Undesirable Effects Reports) Annual reviews for Medical Devices Periodic reports (e.g. DSURs, PBRERs) Risk Management Plans Literature review for the purposes of signal detection or evaluation Retrieve relevant data for evaluation of signals using appropriate sources of information and database searches Analysis and presentation of data for signal evaluations Provide information for investigations related to product quality issues Consumer Safety contributions for global regulatory submissions Responses to regulatory questions including local label deviations from the company core data sheet Regulatory supporting documentation for labelling updates Desired Candidate Profile Bachelors, or above, degree in Biomedical or Health Care related speciality Experience in scientific literature review, data gathering, data synthesis, analysis and interpretation Competent medical/scientific writing skills Sound computing skills Knowledge of relevant pharmacovigilance regulations and methodologies applicable to consumer safety activities. Knowledge and experience of the principles of causality assessment and the evaluation of safety signals Basic understanding of therapy areas of assigned products Basic knowledge of some other relevant disciplines (e.g. statistics, pharmacoepidemiology) Basic knowledge of medical and drug terminology . Basic understanding of drug development process Basic understanding of drug approval process in major countries Demonstrates planning and prioritization skills Attention to detail but demonstrates pragmatism where appropriate Self-motivated, results driven and capable of working independently Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK’s commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Expected salary:
Location: Hyderabad, Telangana
Job date: Fri, 11 Feb 2022 23:58:20 GMT
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