AstraZeneca Pharmaceuticals LP Senior Pharmacovigilance Scientist in Gothenburg, Sweden
Senior Pharmacovigilance Scientist within Respiratory, Inflammation, Autoimmunity (RIA) and Cardiovascular, Metabolic Disease (CVMD)
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality.
Are you looking for a position where you truly can make an impact and have the opportunity to collaborate across global boundaries?
We are looking for two Senior Pharmacovigilance Scientists in Patient Safety RIA and CVMD therapeutic areas.
As Senior Pharmacovigilance (PV) Scientist you lead reviews and interpretations of safety data obtained from patients who have been administered the assigned medicinal product in clinical development programs and/or from marketed use. You also present safety data and analyses in different fora and you lead PV input to safety documents and regulatory reports.
As a member/leader of the safety surveillance team for the assigned product/products, you will be working with a team of patient safety experts (physicians, other scientists) and collaborating with colleagues from across AstraZeneca and externally. Areas of responsibility include:
Leads 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.
Leads Patient Safety 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.
Has the ability to perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects.
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 the collaboration with GSP and Clinical representatives and authors the Reference Safety Information (RSI) for multiple or complex development products.
Authors/provides strategic input or oversight for multiple 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.
Participates in negotiations and provides expertise to the Patient Safety component of contracts/agreements with third parties to ensure quality and integrity of agreements.
Trains and mentors junior members of the team, e.g. in approved PV processes, analytic methodologies, etc.
Minimum requirements in experience and competence:
A life sciences/pharmacy/nursing degree, and demonstrated Patient Safety and/or Clinical Development experience
At least 5 years’ experience in pharmacovigilance and drug development activities from a Patient Safety perspective
Good knowledge of PV regulations
Advanced understanding of scientific methodology
Good understanding of epidemiology data
Demonstrable leadership skills
Able to work with autonomy
Able to work effectively as part of or as the lead of a cross-functional or global team
A flexible, team orientated attitude, willing to contribute own skills to deliver AstraZeneca priority projects
Proven ability to deal with complexity under time pressure
Able to acquire and assimilate knowledge in different disciplines, disease and therapeutic areas
Proven communication skills, interest in and knowledge of cultural diversity
Able to influence whilst maintaining independent and objective views
Good attention to detail
Fluent in written and spoken English.
Maintains high ethical standards in compliance with Good Clinical Practice (GCP)
MSc/PhD in scientific discipline
Project management experience
Previous working experience from pharmacovigilance activities in a Pharmaceutical company, Academic research or Health Authority environment is an advantage
MAA/NDA/BLA submission experience
Location: Gothenburg, Sweden
Reports to: Pharmacovigilance Science Director Patient Safety.
For more information about the position please contact Ing-Britt Joelson at +46 31 776 12 35 or Ann-Christin Arfwidsson +46 31 706 47 61.
Welcome with your application no later than October 22, 2017.
If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do – join us.
At AstraZeneca we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we’re on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you’re swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.