The Pharmacovigilance Lead Consultant must be a health care professional (advanced degree preferred), ideally with 10 years of pharmaceutical experience, with the majority of time having been spent in Pharmacovigilance or in a similar discipline. Additional skills include:
- The ability to interact at a senior level with clients and Fiore Healthcare colleagues.
- The ability to interact with regulators, if required.
- The ability to synthesize clinical data to prepare a complete, accurate and cogent summary of a safety issue, including appropriate analysis.
- The ability to prioritize and handle multiple projects simultaneously.
- Extensive knowledge of U.S. and global regulatory requirements for Pharmacovigilance.
- The ability to learn about new organizations and products quickly.
- Demonstrated excellence in oral and written communication.
- Proven people leadership skills.
- Learning on the fly – a quick learner, open to change and challenges, looks for learnings in both successes and failures, strives to identify and apply best practices.
- Ethics and values – adheres to appropriate and effective set of core values, acts in line with those values, rewards the right values.
- Standing alone – will stand up and be accounted for, doesn’t shirk personal responsibility, can be counted on when times are tough, comfortable working alone on difficult tasks.
- Self–development – is committed to self improvement, dedicates time to this goal, seeks feedback and uses to improve performance, works to compensate for areas of relative weakness.
- Time management – uses time effectively, works efficiently, is able to prioritize activities, seeks guidance on prioritization when necessary.
- Problem solving – follows a logical approach toward addressing challenges, can identify pragmatic solutions to business questions, can generate several options and appropriately rule them out to yield the best one, involves relevant stakeholders in problem solving exercises.
- Informing – provides information required for people to do their jobs, appropriately informs manager when issues arise.
- Composure – hands pressure with finesse, can and handle stress and be reliable through challenging times, does not show frustration when blocked or resisted.
- Decision quality – makes good decisions based upon analysis, consultation, and judgement; most solutions turn out to be correct over time, is considered a resource for decision support.
- Interpersonal Savvy – Relates well to people of all level inside and outside the organization; builds appropriate rapport and constructive, effective relationships; uses diplomacy and tact; can diffuse high-tension situations comfortably.
- Priority Setting – prioritizes his/her time and the time of others on what’s important; quickly zeroes in on the critical few and puts the trivial many aside; can quickly sense what will help or hinder accomplishing a goal; eliminates roadblocks.
- Thorough knowledge of PV concepts, trends, and terminology (PM and clinical)
- General understanding of risk management and minimization
- Familiarity with quality management within PV, Standard Operating Procedures, etc.
- Detailed understanding of FDA Pharmacovigilance regulations
- Ability to participate in regulatory response creation
- Understanding of Good Clinical Practice concepts
- Proficient in English (read, write, speak)
- Strong presentation skills
- Ability to create effective written communications for senior audiences
- Fluency with Microsoft Office suite, and preferable familiarity with ARGUS and ARISg.
- Some facility with safety database
- Ability to learn new computer interface systems
Please e-mail all resumes to email@example.com. Resumes must be accompanied by a cover letter.