Pharmacovigilance Specialist
vor 1 Woche
The Pharmacovigilance (PV) Scientist is responsible for conducting the PV related work according to ICH-GCP, SOPs, project specific procedures, and applicable regulatory requirements. We offer hybrid working arrangements and full flexibility in working hours to ensure our staff achieve the work-life balance often missing in this role. Responsibilities : Manage project-specific activities which may include preparation or review of safety management plan, data management plan, case report forms (as required), preparing safety databases such as Veeva Vault Safety, ArisG, Argus and cubeSAFETY, prepare configuration documents for each project; preparing slides for project kick off meetings, provide study specific safety reporting trainings to investigators / study team and end to end PV project management. Case processing activities and drafting safety narratives, monitoring of safety mailbox, filing study documents in trial master file (TMF). Manage site and regulatory submissions for both expedited and periodic reports (line listings and DSUR) Act as key contact or point of expertise for team members and external contacts for designated projects / processes Participate in safety reconciliation activities, as requested by client. Liaison with medical monitors / Pharmacovigilance physicians, clients, and study teams as appropriate to clarify information required. Participation in inspection / audit related activities; Assistance in preparation or implementation of corrective / preventative actions relating to case processing. Timely submission of reports to regulatory agencies in accordance with applicable regulations and tracking the details of submissions for compliance. Any other responsibilities as assigned by the line manager. Minimum Qualifications & Experience : Registered nurse / pharmacist or with health / biomedical degree or other related scientific degree / qualification is required. Postgraduate qualifications or certification in clinical trials will be an advantage. 2 years to 4 years of pharmaceutical / CRO experience with focus on safety related areas in clinical trials is required. Knowledge / experience in international drug safety-regulatory reporting obligations and compliance. Experience in coding medical terminologies using MedDRA and WHO-DD, case processing and safety report submission is preferred. Strong computer proficiency and ability to work in specific databases is required / preferred. Ability to follow guidelines and procedural documents is required. Fluent in both written and oral English. Good interpersonal skill to professionally communicate with all levels of the organizations. Good time management & multi-tasking capability. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to contacting you regarding your application. #J-18808-Ljbffr
-
Pharmacovigilance & Product Safety Specialist
vor 3 Wochen
Council of the City of Sydney, Österreich Blackmores VollzeitA leading health products company is seeking an experienced professional to champion product safety and pharmacovigilance compliance. The role involves drafting safety assessments, reviewing documentation for product approvals, and being the subject matter expert in product safety inquiries. Ideal candidates should be registered pharmacists with at least 3...
-
Pharmacovigilance Specialist – Hybrid
vor 1 Woche
Council of the City of Sydney, Österreich Novotech VollzeitA leading clinical research organization in New South Wales is seeking a detail-oriented Pharmacovigilance Scientist to manage safety-related activities in clinical trials. The successful candidate will hold a relevant degree and have 2-4 years of experience in the pharmaceutical or CRO industry. This position promotes work-life balance with hybrid working...
-
Named Safety Contact
vor 1 Tag
Shire Of Denmark, Österreich GlaxoSmithKline VollzeitSite Name: Vallensbaek Strand Delta Park Posted Date: Dec Job title: Full time Named Safety Contact (NSC) / Pharmacovigilance Specialist – Denmark & Iceland – with the possibility of converting to 0.8 position The Medical team in the Denmark & Iceland LOC is dedicated to safeguarding patient welfare and ensuring that all GSK medicines and vaccines are...
-
Quality Specialist
Vor 5 Tagen
Council of the City of Sydney, Österreich i-Pharm ConsultingGruppe VollzeitContract type: Permanent Overview Quality Systems & Operations Specialist Location: North Sydney, NSW Hybrid working, 2-3 days per week in office. We are currently partnering with a growing pharmaceutical organisation to recruit a Quality Systems & Operations Specialist for their Sydney-based team. This is a newly created role, offering the opportunity to...
-
City of Melbourne, Österreich Propharma VollzeitA global pharmaceutical company is seeking a Multilingual Medical Information Specialist fluent in Korean and English. This remote role involves managing medical inquiries, providing accurate responses, and translating documents. Candidates are required to have a degree in Life Sciences or Pharmacy, along with prior experience in the pharmaceutical sector....
-
City of Melbourne, Österreich Propharma VollzeitVietnamese-Speaking Medical Information Specialist (Nurse, Pharmacist, or Life Sciences Graduate) ProPharma is seeking a native Vietnamese-speaking Medical Information Specialist with a background in nursing, pharmacy, or life sciences to join our Medical Information Contact Center. This is an excellent opportunity for candidates comfortable with...
-
Clinical Statistical Programmer
vor 2 Wochen
Council of the City of Sydney, Österreich i-Pharm Consulting Vollzeit2 days ago Be among the first 25 applicants Direct message the job poster from i-Pharm Consulting Recruiting Clinical Operations, Clinical Project Management & Biometrics Professionals across Australia and New Zealand | EDI Champion ANZ Opportunity for an experienced Statistical Programmer to join an independent CRO. You will be a part of a small biometrics...
-
Senior Application Specialist
Vor 4 Tagen
City of Melbourne, Österreich i-Pharm Consulting Vollzeit1 day ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. This range is provided by i-Pharm Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range A$90,000.00/yr - A$110,000.00/yr Senior Field Technical Specialist – CRM (Cardiac...
-
Clinical Research Careers: From Trials to Impact
vor 3 Wochen
Town Of Cambridge, Österreich So Code Limited VollzeitClinical Research refers to the study of health and disease in people, aimed at improving prevention, diagnosis, and treatment of medical conditions through trials and observational studies. This field supports drug development and medical advancements through clinical trials, data collection, regulatory processes, and safety monitoring. It spans all stages...
-
Clinical Research
Vor 2 Tagen
Town Of Cambridge, Österreich So Code Limited VollzeitOverview Clinical Research refers to the study of health and disease in people, aimed at improving prevention, diagnosis, and treatment of medical conditions through trials and observational studies. This field supports drug development and medical advancements through clinical trials, data collection, regulatory processes, and safety monitoring. It spans...
