▷ 3 Days Left Senior Specialist, Icsr Management

Key Responsibilities - Contribute to all aspects of case handling activities from case receipt to expedited reporting and collaborate with stakeholders i e the Safety Evaluation and Risk Management SERM group local operating companies LOCs and clinical operations sciences to ensure that documentation and processes are in place to achieve successful recording and reporting of safety data during the life cycle of a clinical trial and marketed product Work across a complex matrix environment to drive high-quality delivery of case management activities that comply with internal standards and external regulatory requirements where problems or issues are identified facilitate investigation into root cause and create corrective preventative actions CAPAs Escalate identified problems or issues to the appropriate Management Personnel with PV Operations Generate new ideas and proposals for global implementation contribute to advancement of PV Operations methodology and processes Ensures third parties vendors develop and implement robust processes to support quality-driven organization Support Technical Associates with enhancement of knowledge and skills for ICSR Management activities Assist with the set-up studies programs including the review of study documents such as protocols contracts Clinical Trial Applications etc safety slides AE SAE forms and attend Kick off Meetings Assist ICSR Management Leads with spot checks in JIRA and other applicable repositories to ensure relevant documents have been filled appropriately Assist ICSR Management Lead with the oversight of study reconciliation activities Escalate to the ICSR Management Lead as needed Review of Safety Management Plans SMP Data Management Plans DMP Protocol Data Entry Guidelines PDEGs and complete start-up close out checklists Prepare and submit safety database configuration requests review User Acceptance Testing UAT outputs for Electronic Data Capture EDC and Safety Database SDB assist the ICSR Management Lead in vendor training Review and maintain oversight of training materials developed by third parties vendors Monitor key performance indicators KPIs generated from supplier and quality organizations determine appropriate responses to manage and mitigate risk and identify issues for escalation action as required Maintain awareness of CRO licensing partner reporting rules and ensure case handling is aligned with reporting timelines and expectations demonstrate expert working knowledge of the regulatory environment on a global level Manage PV Operations mailboxes for Spontaneous and Clinical Trial queries and provide timely responses to queries Job-Related Skills - Knowledge of Good Clinical Practice GCP Clinical Trial Regulation CTR and Good Pharmacovigilance Practice GVP clinical safety documentation reporting of adverse events from clinical trials local regulatory requirements and pharmacovigilance methodology general understanding of worldwide regulatory requirements Working knowledge of principles of data collection manipulation and retrieval and experience summarizing data In-depth understanding of medical and drug terminology Proven experience of prioritisation and time management Strong communication skills In-depth knowledge of safety databases strongly preferred Job Purpose - ICSR Management Argus Configuration for new Programs Studies ICSR processing Case Processing Coding Conventions Local Operating Companies LOC Interactions Functional Vendor Oversight New Market Authorisation Withdrawal of Market Authorisation PAC awareness Clinical Trial Program Interactions for Study Program Set up Study Program Maintenance Study Program Close out Argus Configuration for Submissions to destinations including Regulatory authorities Partners Clinical Research Organisations CROs LOCs Clinical Operations CROs Why GSK Uniting science technology and talent to get ahead of disease together GSK is a global biopharma company with a purpose to unite science technology and talent to get ahead of disease together We aim to positively impact the health of 2 5 billion people by the end of the decade as a successful growing company where people can thrive We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines We focus on four therapeutic areas respiratory immunology and inflammation oncology HIV and infectious diseases - to impact health at scale People and patients around the world count on the medicines and vaccines we make so we re committed to creating an environment where our people can thrive and focus on what matters most Our culture of being ambitious for patients accountable for impact and doing the right thing is the foundation for how together we deliver for patients shareholders and our people 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 It has come to our attention that the names of GlaxoSmithKline or GSK or our group companies are being used in connection with bogus job advertisements or through unsolicited emails asking candidates to make some payments for recruitment opportunities and interview Please be advised that such advertisements and emails are not connected with the GlaxoSmithKline group in any way GlaxoSmithKline does not charge any fee whatsoever for recruitment process Please do not make payments to any individuals entities in connection with recruitment with any GlaxoSmithKline or GSK group company at any worldwide location Even if they claim that the money is refundable If you come across unsolicited email from email addresses not ending in gsk com or job advertisements which state that you should contact an email address that does not end in gsk com you should disregard the same and inform us by emailing askus gsk com so that we can confirm to you if the job is genuine