The general responsibilities for the Senior Pharmacovigilance Scientist are the same as for the Pharmacovigilance Scientist, although it is expected that given greater knowledge and experience such responsibilities may be required for one or more products of high business priority and/or complexity.
Working with the Global Safety Physician (GSP), take responsibility for aspects of the Clinical Safety strategy for assigned AstraZeneca-MedImmune drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level.
Identify opportunities for, or the need to, enhance existing processes through their knowledge of internal and external environment.
Contribute toward and may lead aspects of the scientific elements of pro-active safety evaluation and risk management for large AZ/MedImmune products or product groups in the clinical development, submission and/or the post-marketing setting
In conjunction with the safety physician, proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources in order to predict / establish the safety profile of compounds in clinical development, including employing expert groups and methodologies such as SKG's, Safety Science, Informatics expertise, modeling and simulation to manage the risk to patients.
Works collaboratively with experts from across AZ-MedImmune (e.g. Pre-clinical safety, Safety Knowledge Groups, Safety Informatics Scientists and Safety Science, Global Regulatory Leads), as well as colleagues from all three Science Units as leader/member of a Safety Management Team/ MedImmune Safety Review Team or as a member of other cross-functional project teams, thereby promoting high quality evaluation of safety data.
Utilises safety knowledge or innovations to provide safety design insight across the development programme.
Ensures, in conjunction with the GSP, that the emerging safety profile links to the target product claims/profile and that the appropriate patient safety objectives and risk minimisation strategies are included in clinical development programmes.
Leads and/or contributes to the scientific inputs to determine the Risk element of the Benefit/Risk evaluation.
Provides scientific leadership/ input and review for strategic AZ/MedImmune safety and regulatory documents, including (developmental) Risk Management Plans, safety inputs to internal governance documentation, Health Authority Queries, Submission Documentation, and Periodic Reports.
Mentors junior staff; development and provision of training within specific areas of knowledge.
In addition to the above accountabilities, may also act as SaMT leader on designated products. (Refer to the SaMT leader role descriptor for SaMT leader accountabilities/responsibilities)
The principal responsibilities for the Pharmacovigilance Scientist/Senior Pharmacovigilance Scientist are summarised below.
Safety Governance and Risk Management activities
Working with the Global Safety Physician (GSP), take responsibility for aspects of the Clinical Safety strategy for assigned AstraZeneca-MedImmune drug projects and products throughout all stages of development and/or when on the market, including implementation and communication of the strategy at the project team/governance level. The strategy includes, but is not limited to: definition of identified and potential risks and proposal of relevant mitigation and minimization measures ; safety go-no go criteria for the clinical programme; safety input to TPP/TPC; an integrated pre-clinical and clinical safety view; Outline of the safety database to launch, safety submission strategies; and the risk component of the benefit/risk assessment.
* Leads and/or conducts proactive pharmacovigilance and risk management planning for designated products, including preparation of the safety aspects of the global Risk Management Plans, in partnership with the Global Safety Physician (GSP) and senior clinical team physician.
* In partnership with the GSP, provides the clinical safety input into Clinical Development planning activities.
* Represents PS on cross-functional Clinical Teams and/or Project Teams for developmental compounds and/or marketed products.
* May provide input on cross-functional ad-hoc teams set up to address urgent and important safety issues.
* Reviews and provides technical insight to investigator brochures, protocols, informed consents, final study reports and external data monitoring committee charters.
* May present safety information at clinical investigator and commercial meetings.
AZ only: As a SaMT (Safety Management Team) leader, ensures that risk-reduction strategies are implemented appropriately in relevant documents such as clinical study protocols and/or product labelling.
MedImmune only: Facilitates establishment of Safety Review Teams as necessary, provides data for review and actively leads and contributes to interpretation and discussion, including facilitation of risk management planning. .
Signal Detection, Evaluation and Labelling
* Runs routine signal detection process in partnership with GSP, for all products in area or responsibility.
* Identifies and uses appropriate sources of information and database searches to retrieve relevant data for evaluation of signals (for MedImmune this could include contributing to initial signal assessment and/or risk assessment reports).
* May take the lead role in data evaluation and discussion of the results with the Safety Evaluation Review Meeting (SERM) Chair (or MedImmune equivalent), GSP and other key stakeholders (e.g. SaMT, MedImmune Safety Review Team, and QPPV).
* Presents on complex/less complex issues to SERM (or MedImmune equivalent), in partnership with GSP.
* Produces accurate and fit for purpose evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
* In consultation with the GSP and Clinical representatives, prepares the Developmental Core Safety Information (DCSI) for assigned development products; co-ordinates meetings and tracks timelines to ensure completion.
* In conjunction with the safety physician, proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to establish the safety profile of our drugs and manage the risk to patients.
Regulatory Reports and Submissions
* Authors/provides scientific input and/or review for periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines. Co-ordinates and leads the compilation of large PSURs or PBRER requiring a PS team approach and provides high-level summaries on major issues.
* Authors/provides scientific input to the patient safety contributions for global regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and liaison with other functional experts (e.g. Clinical, Pre-Clinical, Regulatory).
* Contributes to and/or reviews the PS component of contracts/agreements with third parties (e.g. collaborators, development partners) and escalates any deficiencies to the respective Skills Director to ensure quality and integrity of agreement.
* Advises on the preparation of licensing agreements in therapeutic area of responsibility.
* Participates (along with GSP) in AZ internal meetings with project focus.
* Participates in external non-regulatory meetings including those with consultants and other companies such as licensing partners.
* May assist in due diligence activities.
* Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
* Participates in, and may lead, a process improvement initiative team within PS.
* May contribute to advancement of methodology and process by generating new ideas and proposals for implementation.
* Raises concerns/issues to senior management in a timely, open and appropriate manner; ensures quality and integrity of issue/event being escalated.
* Mentor and train junior members of the team in signal evaluation methodology, risk management, preparation of safety reports or other documents and in new methodologies or ways of working.
Requirements -- Education and Experience
* A life sciences/pharmacy/nursing degree, with at least 3 years Patient Safety and/or Clinical / Drug Development experience, with a background working cross-functionally within pharmacovigilance, medical information, medicines management, pre-clinical or clinical research.
* Demonstrable professional excellence -- adds value by applying expertise proactively
* Good attention to detail
* Good time management
* Fluent in English
* Computer literate
* Comprehensive understanding of Patient Safety regulatory obligations
Associate Principle Specialist Surveillance:
* A life sciences/pharmacy/nursing degree, with at least 5 years experience in the areas listed above.
* Demonstrable leadership skills, able to resolve conflict and think/influence strategically
* Able to work with a high degree of autonomy and effectively as a member of a cross-functional or global team on a complex project.
NB: It is not mandatory to meet the minimum requirements for length of experience; these details are intended to be indicative of the level of knowledge, expertise and recognition required of an individual in this job.
* MSc/PhD in scientific discipline
* Good understanding of epidemiologic data
* Proven good communication skills with ability to work across cultures
* Able to influence whilst maintaining independent and objective views
* A comprehensive understanding of how their role within the function contributes to the overall business
Skills and Capabilities
Leadership (Target level 2):
* Commitment to Customers and Integrity (represents and shapes customer perspectives)
* Strategic Leadership (identifies untapped opportunities)
* Acts Decisively (create clarity for others to act decisively)
* Drives Accountability (creates cross-boundary accountability)
* Works Collaboratively (establishes shared purpose across boundaries)
* Develops People and Organisation (invests in long-term development of others)
Technical (Competent level)
* Drug Development Experience and Application of Disease and TA knowledge
* Integrative thinking
* Excellence in pharmacovigilance
* Patient Benefit risk assessment
Core (Competent level)
* Conceptual thinking (associates seemingly unrelated information, analyses situations, takes long term view)
* Influencing (presents positive image, demonstrates flexibility, effectively facilitates communication applies negotiation strategies and tactics, to reach conclusion)
* Initiative (acts proactively, proposes improvements where appropriate)
* Innovation (stays current on emerging trends and new practices within relevant areas)
* Business relationship management (demonstrates good knowledge of relevant specialist area, develops strategic and collaborative relationships)
Key relationships to reach solutions
* Patient Safety Physician, Scientists and Development function
* Regulatory Affairs groups
* Skills Director, Safety Medical Director and Skills Director PS Enabling Safety Science
* D&E Alliance group
* Risk Management Director/Associate Director
* EUQPPV/Deputy EUQPPV
* Patient Safety personnel, of all levels, across the Regions
* External Service Providers
* Regulatory Authorities (eg FDA, EMA, MHRA)
* External opinion leaders and experts as required
* Direct Reports - none
* Indirect Reports -- none
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation
Special NotesThe work location for this position can be Molndal, Sweden or Gaithersburg, Maryland (US)
There are positions available in multiple therapeutic areas including: cardiovascular, endocrinology, oncology, respiratory, and infection/vaccines.
Note for Gaithersburg:
Successful candidates will be AstraZeneca Employees and will be located at AstraZeneca's MedImmune strategic science center in Gaithersburg, Maryland. MedImmune is the worldwide biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines.
NoticeAstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency.
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit www.astrazeneca.com.
Making a Difference
AstraZeneca is an equal opportunity employer