Drug Safety administrative assistant

4 weeks ago

Richmond North Yorkshire, United Kingdom ProPharma Full time

Company profile

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Role

The Drug Safety Assistant is responsible for providing administrative support for all aspects of the adverse event and product quality complaint follow-up services provided for the clients of ProPharma, including generating follow-up letters, reporting received follow-up information and tracking all actions into a follow-up database. The role also provides comprehensive administrative support to the Medical Information (MI) Enquiry Handling teams and Senior Management in an accurate and efficient manner.

Please note, this role is fully onsite for the 3 month probation period and then can be worked on an Hybrid basis (2-3 days in the office, remote based otherwise).

Responsibilities

(Supervision, mentoring and advice will be provided to support the Drug Safety Assistant in the conduct of the responsibilities listed below:)

  • General administrative duties as delegated by management.
  • Answering the main telephone line of the Company in a professional manner and transferring calls as appropriate.
  • On an ad-hoc basis providing reception cover which includes meeting, greeting, and signing in all visitors to the ProPharma office in a friendly, courteous, and professional manner.
  • Supporting the filing clerks, including opening the daily mail received into the company, franking, and posting the mail, filing, archiving and checking stationery stocks.
  • Effectively perform in at least three task areas. Follow-up Service Specific Responsibilities
  • Typing and formatting of Adverse Event (AE) and Product Quality Complaint (PQC) follow-up correspondence (letters, faxes, emails), including assembling necessary enclosures and attachments.
  • Quality checking the correspondence produced and sending the correspondence to the customers within the deadlines detailed in the client Working Practices (WPs).
  • Adding received solicited follow up information to the AE/PQC report forms, quality checking the report and sending the report form to the client within the deadlines detailed in the client WPs.
  • Accurately tracking all follow-up actions performed into the client specific databases.
  • In line with the client WPs informing clients on a regular basis when cases have been closed. Quality Assurance
  • Maintaining a good level of quality in all aspects of the job.
  • Complying with the procedures documented in the Company Standard Operating Procedures (SOPs) and Working Instructions (WIs).
  • Having a solid working knowledge of, and complying with, the Standard Operating Procedures of ProPharma.
  • Working in a professional manner at all times, with clients, customers, team members and management.
  • Complying with the Company’s Health and Safety Policies.
  • Ensuring the Confidentiality Statement within the Contract of Employment is always adhered to in respect of the data and property of ProPharma, its clients, and employees of the business.
  • Ensuring that any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations as described in ProPharma SOPs.
  • Other duties as assigned.

Necessary Skills and Abilities:

  • Able to work within a team in a professional manner.
  • Sound written and oral communication skills.
  • Good accuracy and attention to detail skills.
  • Solid level of productivity on all tasks.
  • Sound organizational and prioritizing skills showing an effective workload management system.
  • Able to understand and follow processes.
  • Pleasant and professional telephone manner.
  • Computer literacy (MS Office).

Educational Requirements:

  • 5 GCSEs or equivalent, including Grade A* – C in Science, English and Mathematics or equivalent education and/or experience.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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