Drug Safety Associate

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

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

What do you get in return:

  • 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
Mám zájem o tuto pozici

Poslat nabídku na e-mail

Další pozice v oboru Zdravotnictví a farmacie, region Prague

FARMACEUTICKÝ ASISTENT - Praha 8 - Libeň

  • Benu
  • Praha hl.m.
  • Dohodou

Najděte jistotu #podnašimikřídly a rozšiřte náš tým v lékárně BENU v Zenklově ulici.

FARMACEUTICKÝ ASISTENT - Praha 8 - Libeň

FARMACEUTICKÝ ASISTENT - Brandýs nad Labem

  • Benu
  • Praha hl.m.
  • 30 - 40 000 Kč/měs

Najděte jistotu #podnašimikřídly a rozšiřte náš tým v lékárně BENU Brandýs nad Labem, OC Tesco.

FARMACEUTICKÝ ASISTENT - Brandýs nad Labem