Associate Director Senior Patient Safety Scientist
AstraZeneca

Job Info

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Job Profile: Associate Director, Senior Patient Safety Scientist

Location: Onsite w flexibility in Waltham MA

At AstraZeneca, we work together to deliver innovative medicines to patients across global boundaries. We make an impact and find solutions to challenges. We do this with integrity, even in the most difficult situations, because we are committed to doing the right thing.

This is an opportunity to further develop your pharmacovigilance (PV) experience in safety programs, spanning the entire life cycle of drug development and pre or post submission. Our Scientists and Physicians play a strategic role in developing our medicines and the safety science of the program. AstraZeneca's product pipeline, includes novel combinations and modalities, provides an intellectual challenge to the safety teams, requiring a broad portfolio and scientific management approach to projects. Our teams' experience develops as our portfolio does.

We are looking for an Associate Director, Senior Patient Safety (PS) Scientist to join our Patient Safety department, working in the Patient Safety Biopharma Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians. You will play a role supporting the safety strategy and requirements for your assigned drug project(s). Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams.

Main Responsibilities

• Leads PS 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.
• 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.
• Leads and/or conducts proactive pharmacovigilance and risk management planning for 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.
• Participates in negotiations and provides expertise to the PS 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.

Patient Safety sits within the Chief Medical Office, where we have a crucial role to play. This is an exciting period for us, as well as for those poised to join us. Our strategy and ability to transform our medicines portfolio means we have a drug-development pipeline that presents incredible opportunities to push the boundaries of science to deliver life-changing medicines. Faced with complex disease challenges, we focus on exceptional performance to drive the best and most progressive drug development programs ever!

Minimum Education, Experience and Skill Requirements

• A Bachelor's in sciences/pharmacy/nursing degree or related field
• 3+ years of proven experience, preferably in industry
• Patient Safety and/or Clinical/Drug Development with proven experience working in safety &/or scientific activities in at least 3 of the following areas:
  • Clinical drug development (Early and/or Late Phase: develop & deliver program level safety strategy, including proactive risk identification & mitigation planning)
  • Post-Marketing Surveillance (including signal detection & evaluation)
  • MAA/BLA (preparation and authoring of the safety related aspects of the Common Technical Document)
  • Periodic Safety Reports (deliver strategy, preparation and authoring)
  • Risk Management Plans (deliver strategy, preparation and authoring)
  • Safety governance board interactions and communication across a range of activities
• Good knowledge of PV regulations
• Demonstrated ability to handle more than one activity simultaneously, prioritizing and recognizing key issues
• Ability to work effectively in an advanced matrix structure
• Proficient in expressive and receptive communications in English language
• This role can sit at our Waltham, MA or Gaithersburg, MD location.

Preferred Education, Experience and Skills

• MSc/PhD/PharmD in scientific field
• 2+ years of relevant experience from pharmaceutical or biotech industry
• Understanding of epidemiology

Employer of Choice

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 because AstraZeneca embraces diversity and equality of opportunity.

AstraZeneca is 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 offer a competitive Total Reward program including a market driven base salary, bonus and long term incentive. We also provide a generous paid time off program and a comprehensive benefits package!

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give 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.

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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