At a Glance
- Tasks: Join a dynamic team monitoring drug safety and supporting global pharmacovigilance efforts.
- Company: Work with a leading global biotechnology company focused on safety and benefit risk management.
- Benefits: Enjoy a hybrid work model, flexible hours, and opportunities for professional growth.
- Why this job: Make a real impact in healthcare while developing your skills in a supportive environment.
- Qualifications: Ideal candidates have a science degree and experience in drug safety or pharmacovigilance.
- Other info: This is an 18-month contract with potential for future opportunities.
Job title: Drug Safety Associate II Location: Maidenhead – Hybrid (2-3 days per week in the office) Contract length: 18 month initial contract Randstad Sourceright, a leading provider of RPO & MSP Recruitment Services are currently recruiting for a Drug Safety Associate II / Pharmacovigilance Specialist on behalf of a global biotechnology company in their Safety and Benefit Risk Management (SABR) business unit. This role is an initial 18 month contract to be based in their Maidenhead offices on a hybrid basis. The Safety Associate II will be a supporting member of the Global Case Management (GCM)/International Pharmacovigilance (IPV) group who performs daily monitoring of expedited submissions and implementation of the overarching Pharmacovigilance (PV) operations as it relates to the businesses Partners, Distributors (International Partner Markets [IPM]), Vendors and the wider PV network that includes stakeholders worldwide and other functional groups including but not limited to Worldwide Medical, Commercial, Quality, Regulatory and Global Marketing. Responsibilities: * Contributes to oversight of Partners, Distributors, Vendors, including metrics, and review of IPM trackers. * Supports the Organised Data Collection Programs (ODCPs) process for AE collection to ensure consistency with regulations and with departmental goals and objectives. * Supports the collection, analysis, communication, and operational change management process for Regulatory Intelligence related to PV in the Distributor Network. * Delivers training, as required, to the Distributor Network employees using a variety of instructional techniques and modalities. * Monitors on-time training completion and follow-up with Distributor Network employees, as applicable. * Prepares data for Distributor Network quarterly meetings and follow-up of action items. * Performs administrative tasks such as: * Attend routine PV meetings for training purposes and ensure compliance with all assigned training. * Produce regular and ad hoc reports to ensure compliance to KPIs. * Investigate and address compliance issues. * Other and document training requirements from meetings and feedback. * Perform ongoing day to day tasks including coordination of training services, reconciliation activities, maintenance of meeting minutes and any other ad hoc projects/activities assigned to meet evolving business needs. * Review queries and coordinate responses related to activities performed by the Distributor Network. * Adhere to local policies related to flexible working. * Supports IPM leadership in the development and ongoing management of technology solutions used to complement the oversight and day-to-today PV activities conducted across the Distributor network. * Contributes to the mechanisms needed to oversee appropriate training of case intake procedures and systems to ensure adequate AE collection in the Distributor Network. * Assists with the controlled document management lifecycle, providing input and monitoring of activities governed by Standard Operating Procedures (SOPs), Job Aids, Distribution Agreements (DAs), Regulatory Services and PV Agreements (RSPVAs), R&D Business Processes, Work Instructions, and reporting forms. * Performs case review activities assigned by supervisor to ensure on-time completion of trackers. * Supports audit and inspections including follow-up of open action items and investigations as related to the Distributor Network. Key Skills / Experience Required: * Experience of working with electronic learning management systems is preferred. * Experience of working in the Pharmaceutical Industry is preferred. * Experience in drug safety and Pharmacovigilance (PV) is preferred – roles such as Safety Associate / Market Safety Specialist etc. Knowledge of good GVP practices is preferred. * Flexibility to support multiple time-zones is preferred. * A degree in a Science or Healthcare related area is preferred. * Highly motivated and a self-starter. * Good written and verbal communication skills. Good technical writing skills with the ability to produce clear, concise documentation and communications. * Good presentation and analytical skills. * Proficient in use of Microsoft Office suite – in particular MS Excel and Sharepoint * Good understanding of PV activities and processes. * Ability to work effectively both independently and as part of a team. We are committed to providing equal employment opportunities and encourage all qualified candidates to apply. While the hiring process may not be expedited, we urge all interested candidates to submit their applications promptly to ensure their consideration. To apply, please follow the instructions on our application portal. We look forward to receiving your application If this isn’t the role you’re looking for right now, please visit our contractor portal below where you will see all of our live roles and communities to join: https://contractortalent.gr8people. eu
Drug Safety Associate II employer: Randstad Sourceright
Contact Detail:
Randstad Sourceright Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Drug Safety Associate II
✨Tip Number 1
Familiarize yourself with the latest regulations and guidelines in Pharmacovigilance. Understanding the current landscape will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those working in drug safety and pharmacovigilance. Engaging with them on platforms like LinkedIn can provide insights and potentially lead to referrals.
✨Tip Number 3
Highlight any experience you have with electronic learning management systems during your conversations. This is a preferred skill for the role, and showcasing it can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss your flexibility in supporting multiple time zones. This is an important aspect of the role, and demonstrating your willingness to adapt can make a positive impression.
We think you need these skills to ace Drug Safety Associate II
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Drug Safety Associate II position. Make sure you understand the key responsibilities and required skills, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize any previous experience in drug safety, pharmacovigilance, or related fields. Be specific about your roles and achievements that align with the responsibilities listed in the job description.
Showcase Communication Skills: Since good written and verbal communication skills are essential for this role, provide examples in your application that demonstrate your ability to produce clear documentation and effective presentations.
Tailor Your Application: Customize your CV and cover letter to reflect the language and keywords used in the job description. This not only shows your attention to detail but also helps your application stand out to hiring managers.
How to prepare for a job interview at Randstad Sourceright
✨Understand Pharmacovigilance Basics
Make sure you have a solid grasp of pharmacovigilance principles and practices. Be prepared to discuss your understanding of adverse event reporting and the importance of compliance in drug safety.
✨Showcase Your Technical Skills
Highlight your experience with electronic learning management systems and proficiency in Microsoft Office, especially Excel and SharePoint. Be ready to provide examples of how you've used these tools in previous roles.
✨Demonstrate Communication Skills
Since the role involves training and communication with various stakeholders, practice articulating your thoughts clearly. Prepare to discuss how you've effectively communicated complex information in past positions.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities in real-world scenarios related to drug safety. Think of examples from your past experiences where you successfully managed compliance issues or coordinated training.