Safety Physician
Who we are …
spmd – safety strategies for health Inc. (spmd) is a contract pharmacovigilance service provider working with various pharmaceutical companies from all over the world. We are a company with German roots and are located north of Boston, MA.
We have a close collaboration with our pharmacovigilance partner enterprise in Germany, spm² - safety projects & more GmbH.
If you are looking to work in a challenging international and complex environment within a developing company, are eager to learn and grow with us, we are happy to receive your application.
Who we are looking for …
spmd is seeking a part-time Safety Physician interested in working in the pharmaceutical sector on a global level and within an international team.
Job Description:
As a Safety Physician with spmd, you will support various pharmaceutical companies to continuously monitor and evaluate the safety profile of their drugs or medical devices.
We have implemented technologies and procedures for remote working; however, we do expect that employees come into the office on a regular basis for a couple of days per week.
You will be trained by experienced staff with a comprehensive global background (USA, Europe and Asia Pacific) in the area of pharmacovigilance, as needed. Since spmdworks on an international level, you will get to know the applicable pharmacovigilance regulations from different regions.
Through our close cooperation with our German partner company, you will have the unique opportunity to work with an international team including in depth knowledge of the European Regulations.
Some of your responsibilities may include but are not limited to:
· Medical triage and assessment of individual case safety reports regarding potential side effects to drugs and/or medical devices;
· Medical review of Clinical Trial Data;
· Generate aggregate safety reports (e.g. PADERs, PBRERs, DSURs) evaluating the benefit risk profile of drugs and/or medical devices;
· Screen and evaluate medical literature;
· Support of Safety Specialists in answering medical questions.
Required Qualifications:
· Academic degree in Medical Sciences (e.g.: MD, VMD);
· No license or certification required.
Preferred essential skills, knowledge and experiences:
· Strong organizational, teamwork, and interpersonal skills required;
· Attention to detail and a high level of accuracy;
· Fluency in written and spoken English language;
· Sound knowledge of MedDRA and/ or other coding dictionaries;
· Sound knowledge of regulations and guidelines in (Pharmaco-)Vigilance;
· Excellent oral and written communication skills;
· Enjoy working in an international environment in a highly regulated medical field;
· Minimum of 6 months of relevant (Pharmaco-)Vigilance experience, clinical experience or other professional life-science experience;
· Being able to cope with strict timelines and periods of heavy workload;
· Proficiency with Windows: MS Word, Excel, Power Point; and ability to learn new programs as needed.
Job Type: Full-time
Pay: From $100,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
Ability to Commute:
- Topsfield, MA 01983 (Required)
Ability to Relocate:
- Topsfield, MA 01983: Relocate before starting work (Required)
Work Location: Hybrid remote in Topsfield, MA 01983