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Medical Director, Pharmacovigilence

Company: LFB Biopharmaceuticals
Location: Framingham
Posted on: April 10, 2021

Job Description:

It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. The Medical Director PV creates and manages the infrastructure to support the medical component of pharmacovigilance for LFB USA. This involves providing scientific/clinical pharmacovigilance and drug safety expertise with a focus on the identification, evaluation and management of safety risks for LFB USA commercial and investigational products throughout the product lifecycle. Responsibility also includes leading and contributing to the collection, processing, assessment, monitoring and follow-up of Adverse Event reports from clinical trials in compliance with Good Clinical Practices, company SOPs, and other applicable guidelines and regulations as appropriate - US and EU. This individual works cross-functionally with parent company in France, clinical/regulatory teams, internal departments and external resources on PV/Drug Safety related issues and supports adherence to relevant regulatory requirements. The Medical Director PV serves as a critical medical analytic and coordinating role in partnership with the Safety MD/Medical Monitor for investigational and/or marketed product(s). The Director Pharmacovigilance and Risk Management is expected to be equally effective in working collaboratively or independently. She/he must demonstrate effective leadership skills with cross functional partners to ensure that signaling, safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines. For investigational products, this role may also participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. The Medical Director PV also plays a key role in ensuring that the above activities remain compliant with evolving regulations, that respective SOPs and work instructions regarding signaling, ad hoc and aggregate safety and risk management reports are adequate. SPECIFIC POSITION DUTIES (RESPONSIBILITIES, TASKS, ESSENTIAL FUNCTIONS)

  • The successful candidate will have demonstrated successful experience of the above responsibilities in their work. Accountability and a sense of urgency in leading/managing projects is a key success factor for this role.
  • Demonstrated ability to review and analyze clinical data, be able to make assessments and be able to communicate effectively both verbally and in writing. Position will report to the Senior Director of Clinical Development.
  • Oversee and provide guidance for the development of pharmacovigilance strategies for LFB USA commercial products as well as other LFB S.A. products earmarked for the US market through a collaborative and functional relationship with the larger global PV organization in France
  • Responsible for oversight of drug safety processes and drug safety deliverables; manage internal and external safety operations and personnel
  • Provide medical expertise in the assessment of drug safety reports. Lead PBRER/PADER/DSUR strategy and timelines with key stakeholders and vendor. Review, analyze and summarize safety data
  • Contribute to the generation of aggregate safety reports (periodic/development safety update reports, periodic benefit risk evaluation reports)
  • Contribute to the identification, assessment and communication of potential safety signals
  • Serve as a medical resource for the generation and review of clinical trial protocols, investigator brochures and regulatory documents and submissions
  • Contribute to Risk Management Plans and/or Risk Evaluation and Mitigation Strategies for assigned products
  • Provide medical safety expertise in-house and with vendors for all development programs
  • Contribute to the development and maintenance of policies and procedures for safety/pharmacovigilance activities in USA including development of Standard Operating Procedures for safety/pharmacovigilance activities worldwide including development of Standard Operating Procures, Working Instructions and other guidance documents
  • Oversees and guides remediation of any Pharmacovigilance deficiencies cited during regulatory or internal audits
  • Support BLA and IND submissions with safety data. Support submission activities related to safety and provide input/ review CTD modules e.g. 2.7.4, 2.5, integrated summary of safety (ISS).
  • Lead RMP strategy and support RMP updates and REMS reports as appropriate.
  • Key safety representation in Integrated Safety Summary reviews, which may include narrative generation, review and approval for filing related activities.
  • Keeping updated on relevant regulations associated with the above activities. Contributes to initiatives for process improvement and cross-product process consistency.
  • Contribute to training programs, provide safety training at investigator meetings
  • Present safety data and results at internal and external meetings
  • Collaborate with Regulatory Affairs to ensure appropriate reporting of safety information to regulatory agencies
  • Develop relationships with and capture drug safety information from key groups, including partner companies, physicians, nurses and patient advocacy groups POSITION QUALIFICATIONS (EDUCATION, EXPERIENCE, KNOWLEDGE, PHYSICAL REQUIREMENTS)
    • Medical Doctor Degree required with at least 8 years of PV/drug safety experience in a pharmaceutical or biotech company, CRO or regulatory agency
    • Expert level knowledge of pharmacovigilance and risk management and global regulations governing drug/biologics safety activities both during clinical development and post marketing
    • Excellent working knowledge of US and EU drug safety regulations, CIOMS and ICH guidelines
    • Working knowledge of MedDRA
    • Experience in regulatory requirements/guidelines pertaining to drug safety
    • Strong leadership capabilities; influential, flexible, pro-active
    • Demonstrated ability to work cross-functionally
    • Excellent communication; verbal, written and presentation skills
    • Strong commitment to business ethics
    • Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
    • Excellent project management skills
    • Advanced ability to use all Microsoft Office applications, strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects) and Argus Safety systems
    • Strong safety database experience
    • Ability to travel internationally If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us! Posted 30+ Days Ago Full time R181 About Us Today, LFB is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals with plasma-derived or recombinant medicinal products in three major therapeutic areas: immunology, haemostasis, and intensive care.
      --Life of patients is our purpose! Let's Work together in a climate of sharing, mutual exchange, trust and transparency.
      We are committed to hiring a diverse and talented workforce. AA/M/F/D/V. This organization participates in E-Verify.

Keywords: LFB Biopharmaceuticals, Framingham , Medical Director, Pharmacovigilence, Executive , Framingham, Massachusetts

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