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Pharmacovigilance Scientist

Job description

We are looking for a pharmacovigilance professional to join the ranks of PV Scientist in an international pharmaceutical client

Contact

If you are interested in these job apply below. I also have more senior roles within QC, QA, QP, RA, PV,  Validation, CQV, and other areas of pharmaceutical, medical device and biologics companies. Send me an email to schedule a confidential chat (014744692) - to "andrius at sigmar.ie" about roles or salary levels within the sector.

Job Duties:

    • Delegated tasks from QPPV/ Deputy QPPV/ Senior PV Scientist on a defined and ad hoc basis with the flexibility of mind-set and time resource this entails. This will include representation at meetings when required.
    • Review and advise regarding relevant local and global guidelines, policies, internal procedures and SOPs across Affiliate companies
    • Manage outsourced data collection, organisation and preparation with vendors as required
    • Act as Subject Matter Expert (SME) in designated area (e.g. literature, signal management, aggregate reports etc.) responsible for oversight and coordination of tasks related to that area
    • Preparation of ad-hoc and scheduled aggregate safety reports
    • Ensure Good Documentation Practice
    • Maintain awareness of Pharmacovigilance regulatory requirements and developments
    • Contribute to agreed PV Team quality and compliance targets
    • Serve in a leadership capacity for complex and strategically important Pharmacovigilance developmental programs
    • Direct interaction with Regulatory Authorities

    Financial:

    • Identification of project challenges to departmental line management and the financial impact thereof.

    Medical Writing Accountabilities:

    • Write clinical documents for submission to regulatory authorities, including but not limited to:
    • clinical overviews and summaries
    • integrated summaries of safety and efficacy
    • Clinical Expert Statements
    • Provide medical editing review of draft and final documents prepared by other team members before internal or external distribution. This includes both copy editing and content review.
    • Ensure document content and style adheres to FDA/EMA or other appropriate regulatory guidelines, and complies with SOPs and style guidelines.
    • Perform literature searches/reviews as necessary to obtain background information and training for development of documents.

    Safety:

    • Creation and update of SOPs/WINs for all pharmacovigilance activities related to the job role in line with worldwide Pharmacovigilance and EU regulations/guidelines
    • Oversee training and mentoring of other Pharmacovigilance staff, and prepare training materials as requested
    • Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
    • Maintain a high and up-to-date level of product and therapy area knowledge by attending conference, training courses, reading relevant medical and scientific literature
    • Preparation of aggregate safety reports including but not limited to PSURs, PBRERs and Addendum Safety Reports
    • Preparation of Risk Management Systems including but not limited to Risk Management Plans, Dear Healthcare Professional Letters and Risk Communication Plans
    • Manage safety related requests from regulatory agencies and Affiliates to ensure any requests are answered fully and promptly
    • Review worldwide literature for designated products and identify safety issues/ ICSRs in a timely manner
    • Coordinate and prepare appropriately for signal management meetings
    • Signal Management Activities including compilation of Signal Assessment Reports/ Case Series Reviews for potential signals
    • Creation and update of Safety Data Exchange Agreements (SDEAs)

    Training:

    • Oversee training and mentoring of other Pharmacovigilance staff, and prepare training materials as requested
    • Lead initiatives to develop, implement and conduct appropriate training in all aspects of Pharmacovigilance Safety activities
    • Maintain a high and up-to-date level of product and therapy area knowledge by attending conference, training courses, reading relevant medical and scientific literature

    Miscellaneous:

    • Maintain rigorous adherence to written procedures, e.g. SOPs/WINs
    • Adherence to Company Health & Safety procedures
    • Participate in training programmes
    • Any other duties as assigned by your Manager

    Person Profile:

    • Pharmacovigilance practice and procedure
    • EU Competent Authorities and Regulations
    • Marketing Authorisation rules and regulations
    • Knowledge of principles of epidemiology and statistics
    • Good working knowledge of the relevant information sources: including printed publications, unpublished sources, databases, web sites, other departments, external bodies
    • Good documentation practice
    • Knowledge and information sharing
    • Excellent attention to detail
    • Excellent written and oral communication skills
    • Understanding of the principles of information storage and retrieval and skill in their application
    • Awareness of competitor products and activity. Excellent interpersonal and communications skills.
    • A solutions provider with strong multi-tasking abilities
    • Manage evolving deadlines effectively with regular feedback and updates.
    • Enthusiasm and drive to take ownership and drive process initiatives.

    Work experience

    • Biological/life Sciences Degree or equivalent
    • Documented experience in all aspects of pharmacovigilance
    • Experience working with safety databases
    • Experience writing large safety reports e.g., DSURs, PADERs, PSURs, PRBRERs, RMPs is desirable
    • Experience working with MedDRA coding dictionary

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