Pharmacovigilance Senior Manager
Would you like to join and contribute to an award winning and successfully growing multinational organization? SFL has been awarded as one of the 10 best companies to work for by Great Place to Work in 2018.
SFL Group and its dynamic cross-functional team provide premium consulting support in the healthcare and life science field. Our clients range from innovative start-ups to top 10 pharma and medtech companies.
We have an opening for Pharmacovigilance Senior Manager.
At SFL you have an excellent opportunity to apply and further develop your knowledge and experience in pharmacovigilance in a multinational and intellectually stimulating environment.
- Manage assigned PV projects
- Act as PV Responsible Person
- Managing PV audits/inspections
- Timely conduct of periodic activities and preparation of periodic reports for assigned products
- Support team in writing safety section of documents
- Support team in preparation of periodic safety reports
- Assist with internal and external drug safety audits
- Remediate any pharmacovigilance deficiencies found during regulatory or internal audits
- Assist with pharmacovigilance processes, preparation of SOPs, product safety reviews and literature reviews as required
- Work closely with clients, partners and colleagues to ensure proper collection and follow up of AE case reports and reconciliation of collected data as required
- Ensure timely case processing: triaging, data entry, coding of AE information, quality control and submission of expedited ICSRs to Health Authorities
- Report Suspected Unexpected Serious Adverse Reactions (SUSARs) to Health Authorities, ECs and investigators
- Review of individual case safety reports according to SOPs and guidelines
- Electronic reporting to Health Authorities
- Business development activities
- University degree in life science
- At least 3 years experience in drug safety
- Systematic thinking, organization skills, flexibility and solution-oriented mindset
- Hands-on experience and attention to detail
- Excellent communication skills in interactions with clients and authorities
- Knowledge of ICH guidelines, European and Swiss Pharmacovigilance regulations
- Excellent skills in English are a must (verbal and written), advanced German knowledge desired
- Swiss or EU/EFTA citizen, or valid Swiss work permit
We provide innovative and customized services and solutions in the life science field from our offices in Basel, Barcelona, Brussels, Lausanne, London and Vienna.
Our main areas of expertise are Regulatory Affairs, Medical Affairs, Public Affairs, Legal & Compliance, Quality Assurance, Pharmacovigilance, Reimbursement and Supply Chain.
Expertise, innovation, development, respect and ethical aspects are our values and corner stone of our company culture and key to our success and excellent reputation.
We are a rewarding company offering a very competitive package, bonus, additional excellent benefits and an environment to grow.
Please send your application with CV, motivation letter and references only via email to HR_SFL@sfl-services.com (no phone or paper applications).