Job Title: Associate Medical Director, Senior Patient Safety Physician
Career Level: E
Introduction to role:
The Associate Medical Director, Senior Patient Safety Physician independently or in association with senior physicians is responsible for continuous efficient evaluation of adverse event and all other safety information. This role is crucial in predicting and managing the safety profile of marketed products through identifying the need for update to reference safety information and driving proactive implementation of risk management initiatives in accordance with global regulatory requirements.
Responsible for authoring and medical review of aggregate regulatory documents, eg Periodic Benefit Risk Evaluation Reports (PBRERs), addendum to clinical overview (ACO )and (DSURs)
Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature and other information sources to predict / establish the safety profile of complex established products to manage the risk to patients.
Understands the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes.
In addition to the physician accountabilities may also act as SSaMT leader on designated products.
Accountabilities:
As an Associate Medical Director, you will be involved in all safety surveillance activities, providing medical expertise and judgement, signal detection, evaluation and Safety Management Team activities for all complex established products in your area of responsibility.
Provides medical input into Identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals.
Collaborates with external provider representatives in routine signal management activities.
Discusses results of data evaluation with the Surveillance Team and/or appropriate key stakeholders, eg Executive Director, Patient Safety /Patient Safety VP TA, QPPV/Deputy QPPV.
Provides medical input to deliver accurate and fit for purpose safety evaluation documents with clear conclusions in response to internal or regulatory authority requests for safety data.
Provides strategic input into responses to regulatory requests for local label deviations from the company core safety documentation.
Provides medical input to regulatory supporting documentation for labelling updates.
Provides expertise to the medical content of the safety specification, pharmacovigilance plan and risk minimisation activities in the core PRMP, globally reviewed LRMPs for marketed products
Provides medical input to ensuring that risk-minimisation strategies are implemented appropriately in relevant documents such as product reference safety information
Provides input on cross-functional ad-hoc teams set up to address urgent and important safety issues
Authors safety content of Health Hazard evaluation report
Reviews and provides technical input for protocols
Regulatory Reports and Submissions
Provides medical input and review of periodic reports (eg PBRERs, PSURs,, DSURs) and renewal documentation submitted to regulatory agencies.
Other Activities
Contributes to and/or reviews the PS component of Safety Agreements
Participates in external regulatory and non-regulatory meetings including those with consultants and other companies such as licensing partners.
Accountable for maintaining personal readiness in response to internal audit or regulatory inspection.
Participates in 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.
Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers.
Essential Skills/Experience:
- Medical degree (eg MD, MBBS)
- At least 2 years of clinical experience post-registration
- High level of medical competence, with an ability to balance this with industry standards to achieve business goals
- Minimum 6 years of /Patient Safety experience (Pharmacovigilance) (with clear evidence of delivery)
- Total of 11 to 14 years of experience or more
Desirable Skills/Experience:
- Able to work across TAs and Functions
- Experience of supervising Patient Safety colleagues
- A demonstrated ability to understand epidemiological data
Skills and Capabilities
Leadership:
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)
May provide strategic input, capable of leading project and team activities.
Trains and mentors junior level staff within given role.
Technical:
Drug Development Experience and Application of Disease and TA knowledge
Integrative thinking
Excellence in pharmacovigilance
Patient Benefit risk assessment
Core (Professional 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
Internal
Senior Physician peers
Regulatory Affairs Department
Executive Director
Risk Management Director/Associate Director
EUQPPV/Deputy EUQPPV
Patient Safety personnel, of all levels
External
External Service Providers
Regulatory Authorities (eg FDA, EMA, MHRA)
External opinion leaders and experts as required
Reporting Relationship
Direct Reports - none
Indirect Reports – none
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That’s why we work, on average, a minimum of three days per week from the office. But that doesn't mean we’re not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
Why AstraZeneca?
Be the beating heart of AstraZeneca. A science-driven organisation where 'following the science' is backed by investment and bold decision-making. There's no better place to see what science can do. At the cutting-edge of science, it's a place to rethink the future of medicine. For the industry, ourselves, and patients. Work on ground-breaking medicine discovery and development from early to late stage and be at the forefront of answering some of the most complex unmet patient needs.
Take the lead to make a bigger impact! Here we need leadership at every level. Physicians who not only have expertise, but also the ability to build a business case, engage multiple stakeholders, and communicate effectively with different audiences. With that kind of remit comes great responsibility and the opportunity to make a big impact.
Ready to make your mark in R&D? Apply now!
Date Posted
Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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