This role engages in the technical activities performed within the Drug Safety department and works also cross-functionally, providing assistance and support with technical activities to other units within the PV department. Drug Safety Associate executes project-related tasks and activities and is able to delegate activities to other project team members as and if required, and ensures a high quality of the services provided.
What will be your key responsibilities:
Executes tasks associated with assigned projects, including without limitation:
- Act as Project Manager on assigned project(s)
- Oversee the work performed by the project team members and ensure a high standard of quality and timeliness of work delivered to the client
- Maintain project tracking and systems; oversee project resource through time monitoring against agreed project project; and provide agreed reports to Drug Safety department leadership and to clients
- Support the commercial unit in scoping, proposal, and/or contractual agreements preparation;
- Assessment of technical activities required for project setup;
- Participate in business meetings, bid with current and potential clients;
- Participation in the kick-off meetings with clients;
- Local project management (Local literature monitoring, Local ICSR processing, LPPV/LSO management, Monthly reporting and compliance monitoring);
- Processing of safety reports (AEs/SAEs/SUSARs) including from those from clinical trial and post-marketing sources– receipt, triage, safety database entry, quality control, MedDRA and WHO drug coding, expectedness and seriousness assessment, classification, tracking, coordination of medical review and assessment, follow-ups, as required;
- Support expedited submission of ICSRs to concerned parties
- Support the reconciliation of safety reports with the clinical database
- Support periodic screening and evaluation of local country reporting requirements
- Global Literature monitoring;
- Medicinal Product Management (XEVMPD);
- Product documentation (SmPC, IB);
- Management of project related PV contracts (PV service agreements, Safety data exchange agreements);
- Support the development and revision of Safety Management Plans
For graduates: no
Salary: by agreement
- Hybrid or remote working (Use of our offices in various locations, co-sharing workspace or home office options)
- 5 weeks holiday plus national holidays in your given location
- 3 personal days
- Flexible benefits, based on location
- Home office stipend
- Annual bonus program
- Other employee Bonuses (spot bonuses and employee nominated bonuses)
- Dog friendly offices
What experience should you have:
- Bachelor’s degree or graduate in pharmaceutical sciences or related fields (medicine, pharmacy, life sciences) – advanced degree (e.g., masters) preferable
- Minimum of 3 years of experience working in a medical or safety department with robust knowledge of medical terminology
- Previous knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.,) beneficial
- Sound knowledge of PV processes, directives, regulations and guidelines (ICH, GVP, GCP, CIOMS, etc.,)
- Experience working with a safety database beneficial
- Significant experience working with a safety database
- Fluent verbal and written English
- Excellent team player, able to build an effective team
- Organizational and time-management skills, able to prioritize work and adhere to deadlines
- Excellent communication skills
- Maintains a positive, result oriented work environment
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