Vice President, Drug Safety and Pharmacovigilance
Our client is a late clinical-stage biopharmaceutical company. They have asked us to assist them in a search for a Vice President, Drug Safety and Pharmacovigilance
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Develops and implements pharmacovigilance guidelines to ensure the uniform and timely processing of adverse events for therapeutics in clinical development and post-approval.
- Directs the safety assessment of products, including the compilation and interpretation of individual and aggregate safety data and scientific literature, preparing safety reports, and assessing and communicating changes in the product risk profile to internal and external stakeholders.
- Provides oversight and strategic guidance on decisions related to safety signal detection and investigation activities. Proactively manages the benefit risk profile and related actions and documentation.
- Contributes to the safety sections of clinical study reports, DSURs, IND and NDA filings, publications, briefing book and other related documents. Provides medical expert safety review and input into critical documents.
- Provides strategic and operational support for safety and benefit risk content of regulatory filing documents.
- Ensures that routine signaling activities, assessment and investigation are completed and documented in a timely manner.
- Develops safety management plans.
- Drives the identification of risks and appropriate risk minimization and pharmacovigilance measures in compliance with regulatory requirements.
- Leads product Benefit-Risk Assessments and any needed actions to update patient safety information. Develops Risk Management Plans and Risk-Evaluation and Mitigation Strategies.
- Responsible for safety content of program documents, including clinical protocols, investigator brochures and informed consent documents.
- Responds to product safety inquiries from all sources including regulatory authorities and ethics committees.
- Maintains and evaluates Medical Safety metrics and quality plan, including execution of metric reports, creating summaries of metrics, identifying any possible issues, and creating an action plan and communicating metrics to appropriate teams. Identifies concerns and champion issue resolution.
- Oversees, evaluates, and monitors medical safety and pharmacovigilance activities conducted in partnership with outsourced vendors and contract research organizations to ensure compliance with company policies and regulatory requirements.
- Manages pre- and post-marketing safety surveillance activities and documentation throughout the product lifecycle in compliance with ICH guidelines, FDA and applicable global health authority regulations.
- Ensures audit and inspection readiness at all times.
- Partners with Medical Director to oversee safety monitoring activities for ongoing and completed clinical trials.
- A Medical degree is required. Specialty Board Certification is desirable.
- A minimum of 4+ years of postdoctoral clinical experience is required.
- 10+ years in drug development in a biotech or pharmaceutical company, including a minimum of 8+ years in a safety-related role is required.
- Small molecule and Clinical Neuroscience (CNS) experience is preferred.
- Broad experience in patient care, clinical development and/or knowledge of clinical pharmacology is preferred.
- Global Pharmacovigilance experience, including knowledge of global PV regulations and applicable ICH guidelines is required.
- Experience in drug development, clinical trial methodology is required.
- Must have experience in preparing or contributing to preparation of clinical safety assessments and regulatory reports and submissions involving safety information.
- Requires experience presenting clinical or safety data to major health authorities.
- Strong negotiation and conflict management skills are required.
- Must have strong prioritization and problem-solving skills with the ability to juggle multiple high priority projects and to be flexible as new challenges arise.
- Must be comfortable working in a fast-paced and evolving company environment.
- Experience leading, managing, coaching, motivating, and developing teams is required.
- The ability to perform effectively in a matrixed and dynamic environment is required.
- Requires advanced skills with MS Office and other related software and tools.
- Must have a passion for drug safety.
- Requires elevated levels of ethics and integrity.
- Must be a team-oriented collaborator.
- Must be exceptionally organized, adaptable, and resourceful.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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