spm² – safety projects & more GmbH (spm²) is a contract pharmacovigilance service provider working with various pharmaceutical companies from all over the world. We are a German company with our headquarter being located in Hirschberg, 16km north of Heidelberg, Germany and a small team working from Faro, Portugal.
We have a close collaboration with our US sister company, spmd - safety strategies for health Inc. located north of Boston, MA.
If you are looking to work in a challenging international and complex environment within an established company which is looking forward to further grow, are eager to learn and grow with us, we are happy to receive your application.
We are looking for the next possible date for a
Pharmacist / Biologist / Chemist (m/f/d) as
(Drug) Safety Specialist in Pharmacovigilance
Your main tasks:
- Processing of individual case reports on adverse drug reactions (entry into the safety database, including integrating case-related information to write a comprehensive case narrative, submitting reportable SAEs/ICSRs to health authorities (e.g., FDA, EMA) according to regulatory requirements, etc.);
- Generate aggregate safety reports (e.g., PADERs, PBRERs, DSURs) evaluating the benefit risk profile of drugs and medical devices;
- Generate line listings from the safety database;
- Reconciliation of adverse drug reactions with partner companies;
- Conducting literature searches and analysing scientific literature;
- Generate internal and client-specific written procedures (e.g., Standard Operating Procedures (SOPs);
- Answering medical enquiries etc.
Your profile:
- Pharmacist or degree in natural sciences, biology, chemistry or equivalent;
- Preferable at least 1 year of Pharmacovigilance experience.
General requirements:
- Good English and IT skills;
- 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;
- Ideally (but not essential) experience in the field of drug safety and drug safety databases;
- A working style characterized by high accuracy and diligence;
- Flexibility and a positive attitude in dealing with customer requests;
- Personal responsibility, ability to work in a team and enthusiasm as well as resilience characterize you personally.
Are you ready for a new challenge and do you enjoy working in an international environment? We offer an attractive full-time job in Faro (Portugal) in a future-orientated company. If you are interested and would like to work in a committed and quality-orientated team that values a friendly and collegial working atmosphere, then we look forward to receiving your detailed application documents via e-mail:
spm² - safety projects & more GmbH
Goldbeckstraße 5
69493 Hirschberg a. d. Bergstraße
Tel.: +49 (6201) 84640-150
www.spm2-safety.com
Job Type: Full-time
Work Location: In person
