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Associate Medical Director, PS Physician

Location Bengaluru, Karnataka, India Job ID R-127666 Date posted 11/01/2022

JOB TITLE : ASSOCIATE MEDICAL DIRECTOR PATIENT SAFETY

CAREER LEVEL: E

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 an argument, engage multiple partners, and communicate effectively with different audiences. With that kind of remit comes great responsibility and the opportunity to make a big impact.

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.

About astrazeneca

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration. Always committed to lifelong learning, growth and development

About the team

We’re a team of leading specialists, driven to pursue scientific knowledge. And there’s no better place to learn – from the science, from each other and from our failures.

It’s a dual role as we work on both understanding our patients better and contributing to scientific research. We are always learning from people who live with the diseases our medicines treat. So we can make sure that great science born in the lab can make a real difference to their lives.

About the role

The Associate Director, Patient Safety Physician works independently or in association with more senior safety physician and responsible for continuous efficient evaluation of adverse event and all other safety information in order to predict and manage the safety profile of marketed products through identifying the need for update to reference safety information with global regulatory requirements with minimal supervision.

Responsible for authoring and medical review of aggregate regulatory documents, eg Periodic Benefit Risk Evaluation Reports (PBRERs), addendum to clinical overview (ACO) and Development Safety Update Report (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 marketed compounds to manage the risk to patients with minimal supervision.

Understands the role of the QPPV and contributes to the maintenance of the pharmacovigilance system and processes.

The principal accountabilities/responsibilities for Safety Physician are summarized below. These may be in association with a senior physician as appropriate.

Signal Detection, Evaluation Risk Management activities and Labelling

Involved in all safety surveillance activities, may include medical review of individual safety cases (providing medical expertise and judgement), signal detection, evaluation and Safety Management Team aactivities for all established products in area or 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 partners, 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 LRMPs for marketed products.
  • 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

Regulatory reports and submissions

  • Provides medical input and review of periodic reports (eg PBRERs, 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 increased.
  • Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers.

Requirements – education and experience

ESSENTIAL

  • 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 3 years of Patient Safety experience (Pharmacovigilance) (with clear evidence of delivery)
  • Total of 6 to 11 years of experience

NB: It is not mandatory to meet the minimum requirements for length of experience; this is intended to be indicative of the level of knowledge, expertise and recognition required of an individual in this job.

Desirable

  • Able to work across TAs and Functions
  • Experience of supervising Patient Safety colleagues
  • A demonstrated ability to understand epidemiological data

Skills and capabilities

Leadership (Target level 2 - 3):

  • 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 train or mentor junior level staff within given role.

Technical (Foundation to Competent level for an entry level physician role)

  • 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 and Development function
  • Regulatory Affairs Department
  • Executive Director/Senior Medical 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

WHY JOIN US ?

This is a place of opportunity with the support you need to thrive and grow. You can move around, try different areas and develop new skills.

Most importantly, we get to work on lifechanging medicines for people who face serious conditions. Our innovative discoveries will ultimately have the potential to reach billions of patients’ in need across the globe. That’s why we love it – this is the place to make a greater impact

SO, WHAT’S NEXT?

Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.



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 authorisation and employment eligibility verification requirements.

50056668 E CDPN R&D Oncology (Susan Galbraith (07016555)) (85008610)

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