Reset

Job Search
Filters

Use the options below to filter your job search and trigger a more bespoke result.

Search
  • Project Management

    £50 - £60 per hour
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are partnering with a very exciting Global Biotech Company who specialise in antiviral drugs. They need a strong Medical Writer who is able to support with drafting and editing regulatory documents (CSRs, PIPs, etc.)

    This will be a 5 day a week freelance position for 12 months initially to be based in London (remote working available) and an excellent rate on offer.

    Please let me know if this role is of your interest.

    Email: shakir.hossain (at) skillsalliance.com
    Phone: 0207 220 6232

  • UK

    Project Management

    £50 - £60 per hour
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are partnering with a Global Biotech Company who are experiencing a period of expansion within their Regulatory Affairs department.

    Our client is seeking a Regulatory Affairs Manager for a 12-month period.

    Location: Cambridge (flexibility of home-based work)

    Rate: £55-60 per hour

    Contract: 12 months (37 hrs per week)

    • Awareness of the regulatory procedures in region for MAs, CTAs, post approval changes and amendments, extensions and renewals.
    • Knowledge of drug development Cultural awareness and sensitivity to achieve results across both regional country and International borders.
    • implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.

    Please contact me if you are interested in this opportunity:

    Email: shakir.hossain (at) skillsalliance.com

    Phone: +44 (0) 207 220 6232

  • Project Management

    £85 - £95 per hour
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are partnering with a very exciting mid-sized Biotech who are focussing on bringing a new drug through from the clinical trial to commercialisation across Europe. They need a strong Regulatory Affairs Director who is able to lead the MAA submission and has the experience of liaising with the relevant health bodies.

    This will be a 5 day a week freelance position for 12 months initially to be based in London (full time from home until Government guidelines change) with flex to work from home in the long term and an excellent rate on offer.

    Please let me know if this role is of your interest.

    Email: shakir.hossain (at) skillsalliance.com
    Phone: 0207 220 6232
    LinkedIn: Shakir Hossain

  • Project Management

    Competitive
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    The Director, Pharmacovigilance manages and oversees the company’s drug safety and pharmacovigilance processes, collaborating with cross functional team. The person will be helping with BLA submmion for a rare disease product. The Director will coordinate the development and establish Pharmacovigilance policies in the USA, Europe and other regions, manage their implementation, and ensure standards are established and complied with. Ensures the uniform and timely processing of adverse event reports and submissions to the regulatory authorities. Supports Regulatory Affairs in interactions with regulatory authorities. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements. Oversees the development and preparation of reports for company management as well as external regulatory agencies. Manages and conducts ongoing safety surveillance on company products. Oversees the preparation of new drug application safety updates, investigational new drug safety reports, investigator communications, product labeling/package inserts and other reports as necessary. Participates in oversight of ongoing clinical trials and in the preparation of new drug applications with respect to drug safety. Selects, develops and evaluates personnel to ensure the efficient operation of the function.

    Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform the following:

    • Provide leadership and be a point of contact for all PV-related activities
    • Oversee the development of policies, standard operating procedures (SOP), guidelines for PV
    • Ensure compliance with SOPs, regulatory safety, and PV activities in accordance with national and international regulations
    • Contribute to the authorship of key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, and risk management plans
    • Manage the case review of serious adverse event (SAE) reports from clinical studies to ensure accuracy, integrity and completeness of safety information, and to ensure consistency of medical coding of safety data
    • Ensure the uniform and timely processing and submission of adverse event data, both in clinical trials and post marketing
    • Support the medical monitor(s) of ongoing clinical trials by identifying and evaluating potential safety signals of ongoing clinical trials through the assessment of single case safety reports and aggregate trend analyze
    • Responsible for the strategy for periodic reports and the coordination and writing of these reports such as PADERS, EU PSURs/PBRERS, DSURs
    • Analyze and interpret aggregate safety data and communicate these analyses and interpretation to cross-functional teams
    • Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB and other documents as needed
    • Represent PV in submission teams, ensuring consistency and adequacy of safety in submission documents
    • Oversight of safety surveillance and pharmacovigilance activities for products in clinical trials and post-marketing
    • Lead development of Risk Management Plans, implementation and evaluation of their effectiveness
    • Work in collaboration and manage relationships with vendors to ensure appropriate reporting of safety information to regulatory agencies and the prescriber community
    • Coordinate the development of quality oversight and performance indicators in collaboration with the QA department and ensure routine analysis, trending and improvement activities.
    • Support and interact with Health Authorities and/or internal audit programs with respect to audits and regulatory inspections
    • Ensure safety issues are communicated to the appropriate stakeholders in a timely fashion.
    • Ensure management and oversight of all PV vendor activities

    Qualifications

    To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

    Education/Experience: The ideal candidate will have:

    • Bachelor’s degree in life science or equivalent in a medical related qualification for at least 10+ years
    • Master’s degree at least 5+ years
    • At least 10+ years of experience in working in pharmacovigilance in a pharmaceutical company or a CRO
    • Experience in rare diseases is preferred


    Knowledge, Skills and Abilities:
    Technical Expertise

    • Knowledge of global pharmacovigilance regulatory requirements and guidelines (EMA/541760/2011 Guideline on good pharmacovigilance practices (GVP), 21 CFR 314, for drug/medicinal/biologic.
    • Experience in BLA submissions
    • An advanced understanding of the drug development process, along with clinical trial methodology, GCP, and medical terminology
    • Breadth and depth of experience managing pre-marketing and post-marketing PV
    • Ability to apply technical, line, and business knowledge to contribute to the strategic direction of the Pharmacovigilance post marketing and development programs
    • Strong communication skills, ability to write and speak effectively; actively listens to others, and provides direct feedback
    • Ability to effectively present information and respond to questions from internal and external stakeholders.
    • Detailed knowledge and experience using a global drug safety database, e.g. Argus
    • Proven experience in project management skills.
    • Scientific writing skills


    Teamwork and Collaboration

    • Ability to develop and leverage constructive relationships across disciplines and functions with a broad variety of people; establishes and maintains professional and productive working relationships with team members
    • High level of interpersonal, active listening, and influencing skills; ability to flex these skills in different situations
    • Depth of experience in interacting effectively with cross functional study team members
    • Outstanding communication (written and verbal), negotiation and leadership skills.


    Decision-making

    • Effective decision-making skills that include developing innovative options and/or multiple solutions to resolve complex problems
    • Ability to define problems, collects data, establishes facts, and draw valid conclusions.
    • Ability to analyze and evaluate safety data and make decisions based on the results
    • Recommends potential courses of action to management and/or senior leaders that impact safety of patients, both in development and post marketing


    Autonomy

    • Ability to work independently using knowledge and work experience in ambiguous situations within a work group/ project team/ function. Self-initiates projects.
    • Ability to multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
    • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
    • Exercises foresight and judgement utilizing comprehensive breadth of knowledge and prior work experience and becomes a resource for others

  • UK

    Project Management

    £300 - £350 per day
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are partnering with a very exciting Global Biopharmaceutical Company who are focusing on bringing a new drug through from the clinical trial to commercialisation across Europe.

    They need a strong Regulatory Affairs Associate who is able to support to the Intercontinental & Global Patient Solutions team with initial marketing applications, including responses to regulatory questions, launch activities, variations and renewals.

    This will be a 5 day a week freelance position for 12 months to be based in Cambridge and an excellent rate on offer.

    Please let me know if this role is of your interest?

    Email: shakir.hossain(at)skillsalliance.com
    Phone: 0207 220 6232

  • Project Management

    £50 - £60 per hour
    Apply

    Job
    Application

    You are currently registered and logged onto our site and this form is therefore using the personal details and CV you have saved with your profile. You can amend them here but they won't overwrite your saved account details. The new uploaded CV and/or cover letter will be saved onto your account if it is not exceeding the maximum of 5 documents.

    Before applying for this position you need to submit your online CV. Click the button below to continue.


    Share

    Skills Alliance are partnering with a very exciting Global Biotech Company who specialise in rare diseases. They need a strong Medical Writer who is able to support with drafting and editing documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PSURs, DSURs, etc.)

    This will be a 5 day a week freelance position for 12 months initially to be based in London (remote working available due to government travel restrictions) and an excellent rate on offer.

    Please let me know if this role is of your interest?

    Email: shakir.hossain (at) skillsalliance.com
    Phone: 0207 220 6232