Safety Specialist II

As a Safety Specialist II at our company, your role will involve the following responsibilities: - Authoring and reviewing various Aggregate Safety Reports such as DSURs, PBRERs, PSURs, PADERs, and Canadian Aggregate Reports as required by the project. - Reviewing aggregate safety data, generating line listings (LL) and summary tabulations (ST), and incorporating them into the appropriate templates. - Analyzing safety and regulatory data provided by clients to prepare comprehensive Aggregate Reports. - Conducting literature screening to include significant safety articles in the respective sections of aggregate reports. - Compiling benefit-risk evaluation sections provided by medical reviewers. - Ensuring compliance with internal and external timelines and addressing comments from reviewers. - Participating in audits and inspections by clients and health authorities. In addition, you will be responsible for: - Screening, data mining, and frequency tabulation for potential signals, including signal estimation using appropriate tools. - Drafting signal detection, validation, assessment, and benefit-risk analysis. - Developing Risk Management Plans in alignment with specific SOPs. - Tracking identified signals and monitoring their status. - Supporting the Individual Case Safety Report and Literature review teams as needed. - Assisting in report scheduling and demonstrating a good understanding of medical and Pharmacovigilance terminologies. - Having knowledge of GCP, GVP, ICH, USFDA guidelines, and other relevant regulations. - Possessing basic competence in medical and therapeutic terminology. - Demonstrating a strong understanding of patient safety regulatory obligations. - Being familiar with regulatory and pharmacovigilance guidelines. - Having proficiency in written and spoken English, with additional languages being advantageous. - Having good command over MS Office tools. - Exhibiting soft skills such as motivation, communication, organization, reliability, and teamwork. If you join us in Bangalore, India, you should hold a graduate or postgraduate degree in life sciences, pharmacy, medicine, dentistry, allied health sciences, or related fields. This is a full-time role in the Analyst category under Regulatory Affairs.,