id: MTg1NTE1IDEyMQ

reference: 185515

documentId: 7931164

connectionPointId: 121

lastModificationDate: 1537176181486

Jobbtitel:
Senior Pharmacovigilance Scientist to Patient Safety

Arbetsbeskrivning:
We are recruiting a permanent positions to our team in Gothenburg, Sweden. The Arena Patient Safety covers the entire clinical life cycle of a drug from planning before first time in man to withdrawal of a product from the market. We are looking for a Senior Pharmacovigilance (PV) Scientist to work in the RIA Therapeutic Area. The Senior PV Scientist leads the review, analysis and interpretation of safety data obtained from patients who have been administered the assigned medicinal products in collaboration with the Global Safety Physician (GSP) and other PV Scientist(s). He/she authors and leads PV input to safety documents and regulatory reports. Senior PV Scientist leads meetings and presents safety data and analyses. The Role 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) Preferred experience/requirements: * 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 * MSc/PhD in scientific discipline Reports to: Pharmacovigilance Science Director Patient Safety. If you are interested, apply now! Welcome with your application no later than October 8th , 2018. AstraZeneca is a global, science-driven biopharmaceutical company. We turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Here, we see the impact of our collective ideas and expertise, and the power of science to deliver them. AstraZeneca is proud to provide a unique workplace culture that inspires innovation and cross-boundary collaboration. Within this environment employees are empowered to express diverse perspectives, and are made to feel valued, energized and rewarded for their ideas and creativity. 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.

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2131

abstractJV_contact_0:
Link to the vacancy on the Swedish job board

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbetsgivare Namn: Astrazeneca AB

source: PES-SWEDEN