Associate (PV) at Syneos Health

Posted 6 months ago
Bengaluru, Karnataka
Application deadline closed.

Job Description

Associate (PV)

Syneos Health

Overview why syneos health . syneoshealthlife means we’re committed to our total self culture – where everyone can authentically be themselves. our total self culture is what unites us globally, and we know every person’s unique contributions make a difference. . we believe our success is a direct result of the people who are driving it – you! we value your dedication to care for our customers and patients, so we want to focus on taking care of you. that’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial. . we are continuously building the company we all want to work for and our customers want to work with. why? because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.responsibilities handling of xevmpd (extended eudravigilance medicinal product data) records – for xevmpdindepth knowledge of xevmpd guidelines (e.g. art57… chapter 3.2, splitting of full presentation name, substance name best practice etc.)database to be used- art57 (evweb)review of xevmpd records already submitted by mah: 1) cross-check and update of the information available in the xevmpd record against the source document (e.g. smpc, pil, ma approval letter) attached by the mah to product records 2) identified errors in the records submitted by mah, will be updated and a new version of the xevmpd record will be created.coding of product indications using latest version of meddra.job requirements designation: senior associatequalification: m.pharmacygood written and verbal communication skills (command of english equivalent to level of b2 of the cefr)a minimum of a bachelor’s degree in scientific domain.significant pharmacovigilance industry experience within a pharmaceutical company or at a cro.2-4 years of experience of authoring of pharmacovigilance aggregate reports, including pbrers, psurs, dsurs, paders and rmps, evaluation of aggregate safety data and experience of signal management.good understanding of clinical development processes including principles of clinical study operations, and ich-gcp guidelines.get to know syneos health we are the only full-service biopharmaceutical solutions company in the world. that means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. learn more about syneos health.additional information:tasks, duties, and responsibilities as listed in this job description are not exhaustive. the company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the job description. the company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. further, nothing contained herein should be construed to create an employment contract. occasionally, required skills/experiences for jobs are expressed in brief terms. any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the eu equality directive, in relation to the recruitment and employment of its employees. the company is committed to compliance with the americans with disabilities act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job