Senior Drug Safety Associate Aggregate Reporting

Job Description

Essential Duties and Responsibilities: As Lead Author : Lead/ Co Lead cross functional teams contributing to periodic safety reports in accordance with Global Pharmacovigilance and Risk Management (GPRM) business rules, standard operating procedures (SOPs), and global regulatory requirements. Support roles involved in creation of Aggregate Safety Reports (ASRs) (i.e. PSURs, PADER, DSURs, PBRER s, Addendum to Clinical Overview s, Addendum to PSUR s, Summary Bridging Report s and RMP Updates). Review aggregate safety data from the database and generate line listings (LL) and summary tabulations (ST) and include the LL & ST in the appropriate template. Compile the safety data into the relevant sections of periodic reports such as PBRER, PADER, and DSUR according to the client. Reviews and identify the literature that is selected for inclusion in the regulatory document that may lead to the signal detection. Create all documents in accordance to all applicable SOPs, and convention of the client. Plan, organize, and manage daily work to meet service level timelines and deliverables. Work with the Aggregate Reporting lead to escalate issues or tasks outside the normal scope of work. Provide word and PDF versions of the final signed documents to the client. Participate in internal and external audits and inspections by clients and health authorities. As Quality Reviewer: Quality Review of the regulatory documents before they are sent to the client for review.To share defects, provide feedbacks to the Team.To ensure Turnaround time (TAT) & quality standards are met by the team.EEO StatementBioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/ handicap status or any other legally protected characteristic, Specialized knowledge and skills: Basic competence with medical and therapeutic terminology.Proven ability to analyze and interpret aggregate patient safety data relating to drug productsAbility to work independently but guided by documented procedures, with appropriate support.Proven ability to interpret and follow the patient safety guidelines of the FDA and comparable international regulatory organizations such as the International Conference on HarmonizationProven experience and report writing skills in accordance with agency requirements for content, format and timelines.Able to work effectively as part of a team.Understanding of patient safety regulatory obligations.Should be familiar regulatory &Pharmacovigilance guidelines.Should be familiar with Pharmacovigilance terminology.Excellent attention to detail.Ability to deliver within established timelines.Fluency in English and excellent comprehension.Computer literate.Relevant product and industry knowledge.Experience with relevant software applications.Communication skills:Requires a proactive approach and excellent written/ oral communication and interpersonal skills. Strong interpersonal skills required to interact with clients, management, and peers effectively. Effective cross departmental communication. Ability to document and communicate problem/ resolution and information/ action plans.Desired Technical skillS: Person should be familiar with MS Office Tools.Extensive knowledge of US, ICH, and EU PV and GCP regulationsExcellent strategic decision- making and analytical skillsSafety database knowledgeOther skills:The ability to contribute to a team environment with a high degree of professionalism and skill. Demonstrate flexibility within a dynamic, fast- paced, cross- functional team. Demonstrated ability to complete multiple tasks concurrently and deliver results in a fast- paced environment. Ability to perform under stringent timelines.Compliance:Awareness of organizational policies & procedures governing his/ her job responsibilities. Awareness and compliance of QMS & ISMS policies & procedures and their impact at his/ her job level. Should understand escalation matrix and escalate to the next level whenever incidents happen which are not in compliance with organizational, QMS & ISMS policies and procedures.Working Conditions: Normal office environment.Hours:Standard Hours 40 hours per week, one- hour lunch, Monday Friday. Additional hours as needed.Willing to work in shifts as and when needed,

Keyskills :
safety quality usinessrules standardoperatingprocedures msofficetools msoffice dataentry drugsafety re databaseadministration stronginterpersonalskills medicalcoding policiesprocedures servicelevel