Drug Safety Operations Specialist - Geneva
Meyrin, Geneva, CH
We are recruiting a Drug Safety Operations Specialist based at our headquarters in Geneva. Reporting to the Drug Safety Operations Manager, your mission is to bring operational support in the implementation and management of the whole process of Case Management, Data Management and Safety agreements management, while ensuring ICH/FDA/EMA and Swissmedic Guidelines compliance.
Your main responsibilities are as follows:
- Act as responsible person for oversight of case management: monitoring of our service provider and ensuring daily triage, data entry and quality control for clinical trials safety reports
- Be responsible of the distribution of safety case reports to commercial partners and affiliates, as well as of the expedited reporting to Health Authorities
- Organize regular case reconciliations with internal and external stakeholders including Product Quality Complaints and Medical Information Inquiries
- Support all activities related to the implementation and renewal of Safety Data Exchange Agreements (SDEAs) with commercial partners and other PV Services Agreements
- Retrieve and share relevant safety data from the OM Pharma safety database that can be needed for Aggregate Safety Reports or signal detection activities (Line Listings, Summary Tabulations….)
- Participate in generating monthly Drug Safety metrics for case management activities
- Perform weekly global and local literature review
- Ensure, in close collaboration with any Service Provider, that all subcontracted tasks related to the Safety database, Data management or Case management are properly conducted in due time
- Participate in the set-up, review and improvement of all procedural documents related to Case management, Safety agreements management and Data Management
- Participate to Audits/Inspections as company specialist and implement CAPAs on an effective and timely manner
- Act as the back-up and deputy of the Drug Safety Operations Manager
To carry out this mission, we are looking for a person with the following profile:
- University Degree (Master’s, PhD) in the field of Life Sciences, Pharmaceutical Sciences or Medical Sciences
- 1-3 years of experience in Safety case management within the pharmaceutical industry, experience in Safety Data Exchange Agreements is a plus
- Excellent proficiency in the use of safety databases such as Veeva Vault, ARISg, ARGUS, or others
- Extensive knowledge of Swiss and international regulations (ICH, Volume 9A/10, EMA GvP, FDA regulations and Swiss regulations)
- Full fluency in English; speaking French would be an additional asset
You describe yourself as a team player and you enjoy working in a fast-paced environment. Thanks to your communication and interpersonal skills, you know how to collaborate with other departments and manage cross functional stakeholders. Showing autonomy and proactivity, you are acknowledged as a solution-oriented person endowed with an entrepreneurial spirit.
Would you like to strengthen your drug safety experience within a dynamic and empowering company? Apply as soon as possible and join OM Pharma!
About Us
OM Pharma is a global Geneva-based biopharmaceutical company. It is a leader in the prevention of recurrent respiratory and urinary tract infections and is also active in the treatment of vascular diseases.
It operates worldwide through a strong network of international partners and invests its profits in R&D to develop microbial derived immunotherapeutic products to treat acute and chronic immunological disorders resulting from inflammation and infections.
The company strives to improve the quality of life of patients around the world by providing access to better treatment of immunological imbalances.
For more information, visit the website: ompharma.com.
