Principal Pharmacovigilance Scientist

Astrazeneca Gaithersburg , MD 20877

Posted 1 week ago

Principal Pharmacovigilance Scientist Gaithersburg, MD

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

We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As a Principal Pharmacovigilance Scientist in Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.

AstraZeneca's vision in Oncology is to help patients by redefining the cancer-treatment paradigm, with the aim of bringing six new cancer medicines to patients between 2013 and 2020. A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers. As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.

Main Duties and Responsibilities

The Principal Pharmacovigilance (PV) Scientist role provides expertise to multiple and/or single but complex products in different stages of development as needed. In this role you will provide oversight of safety documents and deliverables for these projects in collaboration with the Global Safety Physician (GSP) and other PV Scientists. You will lead PV strategy for safety documents and regulatory reports.

You will be responsible for leading the strategy for proactive pharmacovigilance and risk management planning of complex or multiple 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. You will provide subject matter expertise in the therapeutic area and across multiple products.

You may lead cross-functional process improvement or other initiatives on behalf of the Patient Safety organization. You will be performing duties as a Safety Strategy and Management Team (SSaMT) Leader for complex and/or multiple products. As a Safety expert you will lead presentation of complex issues to Safety Information Review Committee (SIRC). You will lead safety strategy for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.

You will lead safety strategy for regulatory submissions of new products, formulations or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts. You will be leading negotiations and provides expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements. You will take accountability and lead resolution of complex safety issues and mediate cross-functional agreement.

You may participate in due diligence activities. You will be responsible to provide training and mentorship to new GSPs and PV Scientists in approved processes and systems.

Essential Requirements

  • 5+ years of directly related PV experience combined with a life sciences/pharmacy/nursing degree, and advanced Patient Safety and/or Clinical/ Drug Development experience.

  • Fluent in written and verbal English

  • Advanced knowledge of PV regulations

  • MD/MSc/PhD in scientific discipline, preferred

  • Advanced understanding of epidemiology, preferred

Next Steps Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.



icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Senior Pharmacovigilance Scientist Or Phar

Astrazeneca

Posted 4 days ago

VIEW JOBS 4/21/2019 12:00:00 AM 2019-07-20T00:00 Location: Gaithersburg, US Competitive Salary & Benefits 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. Our Patient Safety team offers a unique opportunity to further develop your pharmacovigilance (PV) experience in safety programmes, spanning the entire life cycle of drug development from pre-clinical and first-time-in-humans through to late stage and peri-submission. Our Scientists and Physicians play a strategic role in developing our medicines and are deeply involved in the science of the programme, leading and delivering all PV requirements. AstraZeneca's oncology pipeline, which includes novel combinations and modalities, provides a unique intellectual challenge to the safety teams and requires a broad portfolio and scientific management approach to projects. Our teams' experience develops as our portfolio does. We are looking for an experienced Senior PV Scientist to join our Patient Safety department, to work in the Oncology Therapeutic Area. In this exciting and challenging role, you will work collaboratively with the Global Safety Physician (GSP) and other PV Scientists and physicians and play a leading role in delivering the safety requirements for your assigned drug project(s). Your ability to work collaboratively will facilitate cross-functional interactions with colleagues from across AstraZeneca and externally, including counterparts within Clinical Project Teams, Global Regulatory Affairs, and Global Commercial teams. As a Senior PV Scientist, you will be instrumental in leading the safety strategy for the assigned drug development programme. This would include aggregating, reviewing, analysing and interpreting safety-related data to generate information to support safety decision-making by prescribers, patients and payers, with the ultimate goal of protecting patients. You will apply your strong PV and scientific experience, knowledge, and skills to lead all aspects of PV, including authoring and / or providing input to safety-related documents, e.g. regulatory periodic safety reports and safety content of marketing authorisation applications. 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 transformative drug development programmes ever. Essential Requirements * A life sciences/pharmacy/nursing degree; an MS/PhD in scientific discipline preferred * Demonstrable Patient Safety and/or Clinical/ Drug Development experience across a range of activities * Strong working knowledge of PV regulations * Good understanding of epidemiology preferred. * Fluent in written and verbal English Demonstrable experience working in or leading safety &/or scientific activities in at least 3 of the following areas: * Clinical drug development (Early and/or Late Phase) * Post-Marketing Surveillance * MAA/BLA submissions * Periodic Reports * Risk Management Plans (authoring/working 'from scratch') * Governance board interactions If you are interested in this position please apply by submitting your resume. Thank you. Astrazeneca Gaithersburg MD

Principal Pharmacovigilance Scientist

Astrazeneca