This is a rare opportunity to join a young, exciting science driven pharmaceutical company.
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research. The company has a newly created vacancy for an experienced Pharmacovigilance Associate Director.
The Associate/Medical Director will have the following specific responsibilities in a team-oriented environment:
Medical review of individual post-marketing safety reports and solicited adverse event reports from clinical studies of company products.
- Conducts medical investigation for the individual case safety reports (ICSRs), including identifying appropriate follow-up requests of important medical information for the proper medical assessment and evaluation of the case report.
- Ensures the ICSRs are medically accurate, complete, with the appropriate coding for the events (MedDRA coding), causality assessment, seriousness, and expectedness criteria for the case reports
- Prepares, write, and/or coordinates assigned aggregate reports (PSUR, DSUR, IND annual, NDA annual etc) to the health authorities and other stakeholders on products.
- Provides medical assessments and evaluations for ad hoc regulatory safety reports, such as responses to health authorities' questions on potential safety issues, labelling changes, and responding to queries from internal and external health professionals.
- Pharmacovigilance safety advisor at cross-functional project team and/or external meetings including clinical trial team meetings and/or multidisciplinary product teams.
- Provides input to the product Clinical Development Team on program objectives and deliverables.
- Leads to the development and preparation of product Developmental Core Safety Information in conjunction with CSPV and Clinical Research colleagues.
- Participates in clinical research and development planning in partnership with the responsible Clinical Research physician.
- Leads the development of Risk Management Plan and/or Risk Evaluation and Mitigation Strategies.
- Defines and coordinates proactive safety monitoring for products in conjunction with other CSPV colleagues and colleagues from other functional areas.
- Uses established analytical methods and statistical tools for signal detection, to identify risks, and/or support clinical safety findings and hypotheses.
- Completes routine assessment of safety signals and prioritization for full evaluation, through signal management team, Safety Review Teams (SRTs), Medical Safety Board (MSB), or labelling review committees.
- Leads the evaluation and preparation of response documents of safety signals to answer internal and/or regulatory requests, and in the preparation of position papers for development and marketed products.
- Assists the Head, CSPV with resource planning and management, and setting of group strategy and vision.
- Mentors and trains PV and staff on new initiatives, regulatory changes and new processes.
- Work on/manage special projects as directed.
- MD with 3 years PV experience (5 years for Medical Director), or PharmD with 4 years PV experience (6 years for Medical Director.
- Solid knowledge of US and European drug safety regulations.
- In depth knowledge of global clinical and post marketing safety regulations and reporting process.
- In depth knowledge of Good Pharmacovigilance Practices (GPP).
- In depth knowledge of Good Clinical Practices (GCP) related to clinical trial safety documentation and reports
- At least 5 years of biotech/pharmaceutical industry experience, including at least 3 year of experience in clinical safety / Pharmacovigilance.
- 3-5 years relevant clinical safety, regulatory, or risk management experience strongly preferred
- Knowledge and experience of safety surveillance, signal detection, labelling analyses, and ad hoc safety analyses.
- Demonstrated experience in the reviews of relevant safety information from all sources, analysis of safety data and produced definitive documents on safety issues for use through the Company.
- Demonstrated experience with development, authorship and review of aggregate reports (PSUR, ASR, IND annual, NDA annual etc), Risk Management Plans, and Risk Evaluation and Mitigation Strategies
- Demonstrated technical writing skills (published medical or scientific papers)
- Ability to leverage a deep understanding of oneself through knowing one's strengths and weaknesses, proactively asking for feedback to balance self-perception, and being resilient to increase one's effectiveness
- Ability to demonstrate belief in one's convictions by having the integrity to express oneself to one's peers and superiors during increasingly challenging circumstances.
- Ability to recognize opportunities and/or issues and applying analytical and creative thinking to maximize performance.
- Ability to focus on delivering excellent results and improving the performance of oneself and of company by taking initiative to try new approaches, while still following the rules (e.g., company, government and ethical), by taking action to surpass one's own past performance, excel at an objective measure or goal, or do something that has never been done before.
- Ability to demonstrate respect for others by seeking to understand how they think about issues and perceive problems and opportunities.
- Ability to express ideas and information clearly and accurately.
- Ability to work cooperatively with colleagues and take initiatives to build relationships despite differences in interest, offering support and help to peers without being asked or proactively seeking input from others to solve problems
- Minimal travel may be required
CVS to Gerry@rftgroup.ie