Since 1858, Dohmen has been driven by the desire to get safe and effective treatments and cures to the people that need them most. As entrepreneurs, we’ve looked for new and better ways of doing this year after year. Today, as Dohmen Life Science Services, we bring the industry’s most comprehensive service array to Medical Device, Biotech and Pharmaceutical entrepreneurs, helping them get farther faster and keeping them focused on innovations that improve lives.
Our behavior is guided by five simple values –
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”
This perspective defines us. How we act, how we do business, how we work with our clients and how we work with each other. They are the essence of what makes us successful. They are what set us apart.
THE POSITION SUMMARY:
The most important aspect of this position is to provide medical expertise in the review and analysis of safety information, assisting clients with the safety data, compliance with PV legislation and guidance, and all medical aspects of pharmacovigilance. 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 SAE 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.
POSITION SUCCESS FACTORS:
- This individual needs to be credible with both internal and external audiences and have unquestioned integrity.
- Gives high priority to client satisfaction.
- Appreciates the importance of this position toward mentorship and guidance of both staff and clients.
ESSENTIAL JOB RESPONSIBILITIES & ANY ADDITIONAL CERTIFICATIONS:
- 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
- Provide clients with PV legislation and guidance information without the need for supervision
- Conduct safety activities in compliance with PV and device safety legislation and guidance without the need for supervision
- Provide pharmacovigilance strategic advice and medical writing
- Business development as directed
- Self education on changing global pharmacovigilance and regulatory legislation, guidance, and inspection finding trends
- Provide medical expertise for clinical protocol development and medical monitoring of clinical trials
- Creation of the safety section in protocols, informed consents, reference safety information and periodic reports (i.e., DSUR)
- 24 hour on call medical monitoring
- Lead signal management and benefit risk evaluation (i.e., PBRER)
- Provide medical and pharmacovigilance leadership at safety leadership meetings
- Medical lead in meetings with regulatory authorities, study investigators, IRBs/ECs and data monitoring committees
- 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
- Lead medical reviewers to facilitate efficient and accurate case review
- This position will provide clients leadership and junior staff mentorship
- Work collaboratively with internal DLSS groups in handling multiple complex tasks against regulatory and business timelines and provide teams with insight and leadership
- 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
KNOWLEDGE AND SKILL REQUIREMENTS / QUALIFICATIONS:
The requirements listed below are representative of the knowledge, skill and/or ability required.
- MD or PharmD or equivalent (D.O., M.B.B.S, etc.) or comparable education
- A minimum of 10 years pharmacovigilance experience.
- 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.
- 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.
- Experience with pharmacovigilance related computer systems and programs.
- Experience managing people and teams are preferred.
- Excellent leadership skills.
- Willingness to mentor others.
- Detail oriented.
- Excellent interpersonal and organizational skills.
- Excellent written and verbal communication skills.
- Ability to work proactively.
- Excellent problem solving skills.
- Good communications skills required.
- Positive Attitude and Energy – Exhibits an upbeat attitude, a genuine interest in others, and a sense of humor. Energizes others and heightens morale through her/his attitude.
- Communication Skills – Possesses the ability to develop and articulate ideas and information that generate understanding and creates a climate that motivates and encourages others to participate.
- Innovator – Transforms creative ideas into original solutions that positively impact the company’s performance.
- Highly Principled – Proves to be a professional of unquestionable integrity, credibility, and character who demonstrates high moral and ethical behavior.
ENVIRONMENT AND CONDITIONS:
Job demands may require long periods of sitting; telephone work and/or computer work. Position may require extended work hours as necessary.