A new opportunity has arisen for a Senior Pharmacovigilance Scientist to join a highly motivated and collaborative team at a biopharmaceutical organisation who are focused on delivering life-changing medicines. This position is on a contract basis and will be located in Gothenburg however there is the flexibility to be remote based within Sweden.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Accountable to lead and/or conducts proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans and Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
• Presents complex issues to Safety Information Review Committee (SIRC) and takes the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP and other key stakeholders.
• Leads PS activities of cross-functional project teams for developmental compounds and/or marketed products.
• Leads and provides safety expertise to Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
• Leads the cross-functional Safety Strategy and Management Team (SSaMT) for large and/or complex projects.
• Leads and authors the Reference Safety Information (RSI) for multiple and/or complex development products and collaborates with GSP and Clinical representatives as needed.
• Authors/provides strategic input or oversight for multiple and/or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
• Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
• Trains and mentors' junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.

Requirements:

• A life sciences/pharmacy/nursing degree and demonstrated Patient Safety and/or Clinical/ Drug Development experience.
• Demonstrated Patient Safety and/or Clinical/ Drug Development experience.
• Advanced knowledge of PV regulations.
• Intermediate understanding of epidemiology.
• Fluent in written and verbal English.
• Advanced knowledge of PV regulations.
• Intermediate understanding of epidemiology is preferred.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.