At Dohmen, we are committed to keeping our clients for life, ensuring no conflict of interest exists, achieving continuous innovation, and focusing on continuous improvement. Our behavior is guided by five simple values that define how we work and are the essence of what makes us successful:
Caring: We are empathetic and respectful. We ask “How can I help you?”
Committed: We are dedicated and persistent. We ask “How can I make it happen?”
Creative: We are inventive and imaginative. We ask “How can I do it better?”
Collaborative: We are cooperative and share our knowledge. We ask “How can we achieve success?”
Courageous: We’re willing to risk failure over inaction. We ask “How can I challenge myself?”
The most important aspects of this position are to provide subject matter expertise in (1) the routine handling and processing of adverse event reporting (ICSR, PADER, etc); (2) consultative interactions with clients for review and analysis of safety information, assisting clients with the safety data, compliance with PV regulations/ legislation and guidance, client/regulatory audits and/or inspections and (3) PV business development via providing potential clients with face-to-face, engaging and confident descriptions of PV processes. In addition, this individual is adept in safety-related discussions with clinical investigators, IRBs/ECs, Data Monitoring Committees and regulatory authorities. This position may also participate in the review of individual safety reports, preparation of medical commentary and analysis, and preparation of safety evaluations in aggregate periodic reports. This position provides supervisory leadership and performance management to PV medical reviewers.
Our people leaders are tasked with delivering excellent business results through the efforts of their teams. These results are achieved by:
- Setting clear direction, effective plans and measurable outcomes
- Ensuring work is accomplished effectively by managing employee performance, work processes and other resources
- Engaging employees to maximize their discretionary effort
- Developing a pipeline of excellent talent to fill future business needs
People leaders must possess both the skills to effectively accomplish these tasks and the emotional intelligence to do so in alignment with our cultural values. In addition to the critical management and leadership tasks listed above, this role also includes the following unique responsibilities:
- This individual needs to be credible with both internal and external audiences and have unquestioned integrity.
- Appreciates the importance of this position toward mentorship and guidance of both staff and clients.
- Serves as a subject matter expert (SME) and may participate as such during Quality activities that include client audits, internal audits, and continuous improvement initiatives.
- Serves as a subject matter expert (SME) and may participate as such during Sales/Business Development activities that include capabilities presentations, bid defenses, and project scoping.
Essential Duties and Responsibilities:
Case and Aggregate Medical Review and Signal Management for Adverse Events, Product Complaints, and Medical Device Reports
- Lead medical assessment of SAE reports, including case narrative accuracy, MedDRA coding, medically relevant queries, expectedness, causality, and reportability
- Create or review the Analysis of Similar Events
- Proficiency in trial and postmarket drug and device safety information processing and analysis
- Provide medical expertise in the review and analysis of case and aggregate safety information
- Lead signal management and benefit risk evaluation (i.e., PBRER)
- Write Health Hazard Evaluations and other similar safety review/analysis documents
- Conduct safety activities in compliance with PV and device safety legislation and guidance without the need for supervision
- Provide medical expertise for clinical protocol development, medical monitoring of clinical trials, data monitoring committees, and safety assessment committees
- Creation of the safety section in protocols, informed consents, reference safety information and periodic reports (i.e., DSUR)
Consulting and Strategic Advice
- Provide clients with PV legislation and guidance information without the need for supervision
- Provide pharmacovigilance strategic advice and medical writing
- Self-education on changing global pharmacovigilance and regulatory legislation, guidance, and inspection finding trends
- Safety labeling development
- Provide medical and pharmacovigilance leadership at safety and corporate leadership meetings
- Medical lead in meetings with regulatory authorities, study investigators, IRB/ECs and data monitoring committees
- Perform as a diplomatic, accurate, and confident subject matter expert during agency inspections (announced and unannounced)
- Provide subject matter expertise during client audits and regulatory inspections
- Serve as the client-facing medical professional for DLSS
- Excellent, engaging client relationship management and communication skills
- Travel to provide potential clients with face-to-face, engaging and confident descriptions of PV processes in support of business development
- Ability to describe PV services clearly to client decision makers in context of company risk, benefit, budget, and regulatory agency compliance
- Travel as necessary potentially 20-40%.
- Provide clients PV leadership and junior staff mentorship
- Oversee and lead medical reviewers to facilitate efficient and accurate case review
- Work collaboratively with internal DLSS groups in handling multiple complex tasks against regulatory and business timelines and provide teams with insight and leadership
- Provide strategic and tactical organizational leadership
- Establish team goals which support DLSS’s corporate objectives and ensure that staff has aligned goals
- Provide sound leadership to direct reports and build an effective and cohesive team
- Responsible for hiring staff, measurement to goals, and performance management
- Demonstrate excellent and efficient performance management skills
The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.
- MD or PharmD or equivalent (D.O., M.B.B.S, etc.) or comparable education in life sciences
- A minimum of 10 years pharmacovigilance experience required
- Knowledge of and ability to interpret and apply international safety regulations
- Demonstrated competence in collecting, analyzing, and reporting safety data in compliance with regulations
- Experience preparing investigational and post-marketing regulatory reports
- Experience developing data analyses and medical evaluation of safety data
- Excellent leadership skills, experience managing people and teams, and a willingness to mentor others
- Detail oriented with the ability to work proactively
- Excellent interpersonal, organizational, and problem-solving skills
- Excellent written and verbal communication skills
- Experience working for a CRO or pharmacovigilance service provider desirable
- Experience with pharmacovigilance related computer systems and programs (e.g. safety database) preferred.
- Experience in the clinical and drug development process in a pharmaceutical /biotechnology company and preparation risk management plans, aggregate reports and company core safety information highly desirable.
Physical and Mental Demands:
Job demands may require long periods of sitting, telephone work, and/or computer work. Position may require extended work hours as necessary.
The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.
This position is based in Emeryville and may require 20-40% travel.
The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.