6 Drug Safety Associates jobs in the United Kingdom

Our client is a market leader within the Pharma Covigilance market. They are looking to recruit a Drug Safety Administrator who will be an active participant in meetings and assist the PV Manager in maintaining standard operating procedures or working practices. During their daily activities, the Drug Safety Administrator will be required to liaise with pharmaceutical companies and other business partners.

Daily tasks:

• Keeping the Pharmacovigilance Manager fully informed of problems and issues that may arise related to the product, adverse events, the patients, prescribers or the marketing authorisation holder.
• Processing selected case reports in the database.
• Checking all literature case reports have the appropriate AE terms assigned for MedDRA coding. Notifying the QPPV of cases where the appropriate MedDRA term cannot be identified independently.
• Reconciliation both with clients and/or with PV partners on behalf of clients (as required).
• Processing reports from any source in the drug safety database.
• Assessing adverse events and carry out listedness and causality assessments.
• Exchanging a PV case reference from the database with PV partners.
• Conducting follow-up investigation for direct reports from either patients or healthcare professionals.
• Maintaining Continued Professional Development in support of your role and responsibilities.
• Participate in various team meetings and liaise with other colleagues about on-going projects.
• Assist with documentation such as Working Practices and Standard Operating Procedures, where required.
• Develop a thorough knowledge of medicinal products and with regulations and guidelines within the industry.
• An organised, proactive person with excellent attention to detail.
• Excellent oral and written communication with proficiency in standard software programs.

Minimum Requirements:

• Life science or Bio medical graduate (1-2 years working experience desirable) or other allied healthcare professional.

Please note candidates will only be considered with the above skills and unfortunately this company cannot consider sponsorship, or a visa status that will need renewing.

Our client, a globally recognized pharmaceutical organization with a strong pipeline of innovative medicines, is seeking a dedicated Senior Regulatory Affairs Specialist with a focus on Drug Safety. This office-based role in Brighton, East Sussex, UK offers a vital opportunity to ensure product compliance and patient safety. You will be responsible for managing pharmacovigilance activities, submissions, and compliance with global regulatory requirements. The ideal candidate will possess in-depth knowledge of regulatory affairs, drug safety principles, and a meticulous approach to documentation and compliance. Key Responsibilities:

• Manage and oversee regulatory submissions related to drug safety, including Investigational New Drug (IND) applications, Clinical Trial Applications (CTAs), and periodic safety update reports (PSURs).
• Ensure compliance with global pharmacovigilance regulations (e.g., GVP Modules, FDA regulations) and company policies.
• Prepare, review, and submit safety-related regulatory documents to health authorities worldwide.
• Liaise with global regulatory agencies to address queries and provide necessary information regarding drug safety.
• Collaborate closely with internal departments, including Clinical Development, Medical Affairs, and Quality Assurance, to ensure integrated safety reporting and compliance.
• Monitor regulatory changes and assess their impact on company products and processes.
• Develop and maintain regulatory submission documentation and databases.
• Contribute to the development and implementation of company SOPs related to regulatory affairs and drug safety.
• Provide expert advice and guidance on regulatory requirements to cross-functional teams.
• Participate in regulatory inspections and audits, ensuring preparedness and compliance.
• Support post-marketing safety surveillance activities and submissions.

Qualifications:

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, or a related field. A Master's degree or equivalent is highly preferred.
• Minimum of 6 years of experience in regulatory affairs within the pharmaceutical industry, with a specialization in drug safety/pharmacovigilance.
• Thorough understanding of global regulatory requirements for drug safety and GxP.
• Proven experience in preparing and submitting safety-related regulatory documents.
• Excellent knowledge of pharmacovigilance principles and reporting requirements.
• Strong analytical, problem-solving, and organizational skills.
• Exceptional written and verbal communication skills, with the ability to articulate complex regulatory information clearly.
• Proficiency in regulatory information management systems and safety databases.
• Ability to work independently, manage multiple priorities, and meet strict deadlines.
• Attention to detail and a commitment to maintaining the highest standards of compliance.
• Candidates must be based in or willing to relocate to the Brighton, East Sussex, UK area for this office-based position.

This is a critical role ensuring the safety and compliance of pharmaceutical products, based in the beautiful coastal city of Brighton, East Sussex, UK .

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .
**Position Purpose**
The Submission Manager, Clinical Trials manages and coordinates the timely, compliant, and accurate delivery of the core submission documents and dossiers to Bristol Myers Squibb (BMS) HA/EC Applicants and CRO. The Submission Manager also participates in the preparation of the CTIS for CT under the EU Regulation
**Key Responsibilities**
+ Prepare and distribute the global Clinical Trial Application dossier and subsequent substantial amendments to country applicants and CROs for submission to ECs and HAs.
+ Prepare the data required in CTIS for global Clinical Trial Application dossiers and their subsequent substantial modifications.
+ Manage the CT Amendment log considering the EU Regulation and determine windows of opportunity for submissions, escalate within BMS
+ Provide support to the Submission Senior Manager/collaborate with the Submission Specialist in CTA preparation activities for initial filings and start up activities, protocol amendments, end of trials and CSR distributions.
+ Ensure consistency of the Clinical Trial application across projects, studies and countries.
+ Lead Program/Study level CTA Tracking Meetings, in preparation of the CTA dossier, ensuring timelines and dossier quality are managed according to expectations.
+ Liaise with country offices and central team (Clinical Supply Operations, Operation Leads, Protocol Managers, Medical Monitor, Safety, Quality Person) to ensure that Clinical trial application activities are in compliance with study timelines, BMS SOPs, worldwide regulatory guidelines and regulations.
+ Comply with the use and maintenance of the available planning & tracking tools (e.g. Veeva - HA submission and approval Tracking system) to generate reports and track the CTA content and associated dates.
+ Escalate to study teams and GSM-CT senior roles observed trends and issues that may impact timely and successful study approval and execution
+ Contribute to the Global Country Requirements Repository by collecting and sharing additional country requirements.
+ Support initiatives for innovation and simplification in the processes to improve the support to the study teams and GSM-CT.
+ Coordinate updates within a Program.
+ Support continuous improvement and compliance initiatives
+ Utilizes technology effectively to support the clinical trial application submission process. Proficient use of CTMS, Tracking systems, Excel trackers, to generate reports and track the CTAp content and associated dates
+ Contributes to other requirements as appropriate to allow proper functioning of the GSM-CT.
+ Support implementation of the EU CT REG Portal from Feb 2022.
+ Provide training/mentoring to the GSM-CT newcomers
**Required Qualifications & Experience**
+ BA/BS degree in a science or technology field, preferred
+ Extensive relevant regulatory submissions experience
**Key Competencies**
+ Expert knowledge of Regulatory Submissions and package content for non-US clinical trial applications to health authorities.
+ Assists in the development of short- and long-term goals for own workgroup in alignment with those of GSM and the R&D umbrella.
+ Resolves problems/difficulties with the assistance of senior team members.
+ Supports other functions as appropriate.
+ Independently facilitate compound/study team meetings.
+ Works Independently and collaborates with other functional areas.
#LI-Hybrid
If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
**Uniquely Interesting Work, Life-changing Careers**
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
**On-site Protocol**
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit careers.bms.com/ ( eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Bristol Myers Squibb is Disability Confident - Employer
A UK Government scheme
**Company:** Bristol-Myers Squibb
**Req Number:** R
**Updated:** :40:14.637 UTC
**Location:** Uxbridge-GB
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.