• Establish appropriate Regulatory reporting processes and coordinate with staff, third party and/or consultants to complete reports within required regulatory timeframes.• Assist in the onboarding and training of PV staff.• Support to Business Development, Therapeutic Strategy, Feasibility and Project Management team representatives with Pharmacovigilance input to pre-RFP meetings, proposal development and Bid Defenses.• Drive Medical and Safety elements of budgets, proposals, and Bid Defense materials in collaboration with other team members.• Establish revenue recognition and profitability review processes (in collaboration with Global Head Finance).• Oversee the completion of CAPA in response to internally identified system/process weaknesses and/or customer complaints related to PV.• Accountable for the financial management of the medical and safety portion of study budgets.• Other responsibilities and ad hoc projects as required.• Support implementation activities to configure the Safety Database, CTMS, EDC and eTMF systems and to draft SOPs describing core processes.• Perform literature surveillance and aggregate report creation. • Represent the Catalyst Team at global and domestic DSMB or EAC committee meetings (both via teleconference and face-to-face) alongside the client, board members, third party vendors and the project team, oversight of the coordination of all logistical aspects and assisting with facilitation.• Interface with various internal and external parties to implement projects, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations, reviewing all contractual documents for accuracy, and coordinating internal and external approvals.• Compile adjudication dossiers and create/submit follow-up to investigative sites. • Oversee the coordination/facilitation of project meetings, review and approve meeting minutes developed by the Safety Associate

•Responsible for the overall coordination of the Serious Adverse Event (SAE) processes for designed projects. •Provide department training and mentoring of Safety Specialists and new employees; in addition to, new procedures or procedures that require review. •Capable of coordinating and managing a global study (specify study phase i.e. I-IV) and being a global lead. •Oversee expedited reporting and assist staff as needed.•Maintain knowledge and understanding of SOPs; current local and global regulations regarding clinical trials, regulatory documents and safety issues. •Coordinate safety database activities for assigned projects. •Participate in contract activities. •Represent PVG at kick off meetings, hand off meetings and Investigator meetings for assigned projects•Reconcile data listings between the clinical/safety database(s) •Ensure any expedited safety reports are notified to applicable Regulatory Authorities, Ethics Committees and Principal Investigators within regulatory timelines. •Review compliance of expedited safety reporting on assigned projects and escalate problems or issues to PVG Manager •Provide project specific safety training to PPD Clinical on assigned projects •Responsible for coordinating and performing adverse event (SAE/AE) triage, data entry into PPD-owned or client provided adverse event database, review of entered cases for quality, consistency and accuracy, follow up with reporter and/or associated HCP, tracking of reports, and reporting activities. •Code adverse event terms and write narratives according to client convention. •Assist with preparation and review of regulatory reports. •Review literature articles/abstracts and process adverse event reports from literature per program and regulatory requirements. •Provide training, mentoring and work direction to more junior level staff, and quality review of data, including SAE and AE reports.

Responsible to review the Medical Reports of the patients.All of the reports should be accurate and error freeDiagnosis should be properly linked to the ICD CodesQueries should be sent to the Doctors in timely manner and should be answered in the given time frame

Review documents including medical records, reimbursements, financial statements, patient enrollment forms and insurance claims to determine whether or not the document contains an adverse event. Record retrieval and review of the document into database. Assess and triage documents containing AE information, differentiating from those which do not contain or “might contain” AE information.

Assist in processing incoming and outgoing Lifecycle Safety data and reports i.e. collecting and tracking incoming Adverse Event (AE) and endpoint reports.Prepare documents, files for meetings and committees where required i.e. endpoint duplication/dossier compilation oversight committees; and any other project related meetingsCreate, track and archive case folders and project files across Lifecycle Safety service lines. File, retrieve and deliver case folders; assist in maintenance of document control room where required and support relevant applications/systems as directed by Operations Team memberCollaborate with operations and other functional groups to help achieve business goals.

Responsible for the organization, control and retrieval on demand of all unpublished clinical study documentations, function essential to the division’s efforts to register drugs with regulatory agencies. Identify each document such as: regulatory documents, adverse events, clinical studies, statistical reports; shipping documents and general correspondence submitted to the central file, categorized and attribute appropriatelyConduct database searches and case reports for FDA submission, and ensure that each document is in compliance with SOPs.

Coordinating with doctors and companies like; BD, Johnson & Johnson and conducting in-service education classes (60-90 minutes) thrice in a week and making presentations for the same. Some of the power point presentations I have assisted in preparing were about Hip & Knee replacement, Burn Healing, Venepuncture, ECG’s. I have personally attended all of these classes.Gathered information of Daily census of the hospital which includes, number of admissions, discharges and deaths, number of patients under individual doctors, number of surgeries, dialysis performed, number of patients on ventilators and IABP (Intra-aortic Balloon Pump), number of catheterization procedures performed and nurse patient ratio in all nine departments to have a check on staffing acuity. At the end of the month making the presentation of the whole data in comparison with previous month’s data.Compiled Infection control statistics and surveillance record on monthly basis.Compiled Incident reports of all departments on monthly basis

Responsibilities included smooth running of all three shifts by coordinating with the trainers of all three shifts and helping students in understanding the ascents and breaking of terms and grammatical rules which implies according to the rules of transcription. Conducting lectures on rules of Medical Transcription and Medical Terminology.Helping students in imitating any technological problem with the help of engineers.