Drug Safety Specialist

THIS IS NOT A REMOTE POSITION.

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 full time Safety Specialist interested in working in the pharmaceutical sector on a global level and within an international team.

Job Description:

As a Safety Specialist 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 spmd works 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.

You will be in contact with Health Authorities like Food and Drug Administration (FDA) or the European Medicines Agency (EMA).

You will be responsible to write safety reports and prepare aggregate safety analyses for drugs and medical devices which are currently under clinical development as well as for on the market products. Your scientific input into the analysis and presentation strategies will be highly encouraged. Also, you will be responsible to submit these reports to the Health Authorities and other health care stakeholders.

You will be responsible to enter information on side effects into our fully validated safety database (case processing) and submit these to Health Authorities as appropriate.

Based on your educational/ professional experience, the Safety Specialist Responsibilities may include:

• Generate aggregate safety reports (e.g., PADERs, PBRERs, DSURs) evaluating the benefit risk profile of drugs and medical devices;
• Data entry of side effects (SAEs and ICSRs) into our safety database including integrating case-related information to write a comprehensive case narrative;
• Submit reportable SAEs/ICSRs to health authorities (e.g., FDA, EMA) according to regulatory requirements;
• Generate line listings from the safety database;
• Conduct medical literature searches;
• Generate internal and client-specific written procedures (e.g., Standard Operating

Procedures (SOPs).

Essential Skills, Knowledge and Experience include:

• Strong organizational, teamwork, and interpersonal skills required;
• Attention to detail and a high level of accuracy;
• Enjoy working in an international environment in a highly regulated medical field;
• Good understanding of scientific data and the ability to compile meaningful and concise narratives and reports;
• 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.

Preferred Qualifications:

• PharmD, equivalent degree (board certification not required);
• At least 1 year of Pharmacovigilance experience.

Job Type: Full-time

Ability to commute/relocate:

• Topsfield, MA 01983: Reliably commute or planning to relocate before starting work (Preferred)

Work Location: One location