Patient Safety Specialist

**Patient Safety Specialist - Singapore**

**ABOUT ASTRAZENECA**
- AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies._ _We are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear - shaping the future by spotting a scientifically-led commercial opportunity and acting now to operationalise and scale it._

**BUSINESS AREA -** **Singapore Marketing Company, Medical Affairs**
- At AstraZeneca we fuse the worlds of Medical and Commercial to spot opportunities and pioneer approaches that better serve our patients. _
- With a strong foundation of science and ethics, we run fast but never compromise on doing the right thing. Working at pace in our ever-changing, ambiguous markets takes creativity and imagination. We always feel supported to do this, learning from our failures and working as a team to win together._

**What you’ll do**
- You will be responsible for managing adverse event reporting from clinical and post-marketed sources for AstraZeneca products in accordance with pharmacovigilance regulations. This involves working closely together with global colleagues both from within the Patient Safety Department as well as other groups in AZ and act as delegate to Marketing Company Patient Safety Manager, as required._
- Your key tasks will include oversight of the AZ PV system and being in a position to assure the following components:_
- _ Awareness of any conditions or obligations and other commitments relating to safety or the safe use of the products. _
- _Ensure the conduct of PV and submission of all PV-related documents is in accordance with the marketing company requirements and Good Pharmacovigilance Practice (GVP)_
- _ Responsible for managing adverse event reporting from clinical and post-marketed sources for AstraZeneca products in accordance with pharmacovigilance regulations_
- _ Ensure the necessary quality, including correctness and completeness, of PV data submitted to the local regulatory authority_
- _ Prepare Local Risk Management Plans (LRMP),and implement associated risk minimization measures. _
- _Ensure a full and prompt response to any request from the local regulatory authority for the provision of additional information necessary for the benefit-risk evaluation of a medicinal product._
- _ Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals). _
- _Act as a Deputy PV contact point for the local regulatory authority support PSM for PV inspections._
- _ Prepare _local Patient Risk Management Plans _and maintain RMP tracker_
- _ Provide Patient Safety expertise and guidance within the local Marketing company (e.g., Marketing, Sales, Regulatory Affairs) related to issue management for key products, risk management, formulating action plan/implementation, information gathering/extracting data, monitoring results of actions plans, and provide safety data expertise_
- _ Ensures that local safety agreements are monitored and maintained_
- _ Ensures that filing and archiving practices follow the relevant AstraZeneca policy and that there is no destruction of safety-related documentation without prior reference to local Patient Safety_
- _ Is responsible for assessment of all non-serious AEs from spontaneous sources and the upgrade of relevant events to serious in accordance with the AstraZeneca Always Serious List & Designated Medical Events (DME) List_
- _ Review and advise on local study protocols; review safety data and write the safety section of local clinical reports_
- _ Address _safety issues as required related to questions arising from customers (HCPs, patients, pharmacists)_
- _ Provide and disseminate key safety knowledge to Marketing Company personnel as required including but not limited to signal detection data, legal issues, key safety literature articles, local regulatory authority advisories._
- Reviews local medical or scientific literature to identify possible case reports, and forwards in a timely manner to the AZ Patient Safety Data Entry Site (DES)
- _ Ensures a local Business Continuity Process (BCP) for Patient Safety is in place and tested at least annually_

**Essential for the role**
- Advanced scientific degree
- 2 years of pharmacovigilance experience
- Working knowledge of Health Authority regulations
- Excellent verbal and written communication skills
- Ability to work collaboratively across functions

**Desirable for the role**
- Understanding of multiple aspects within Medical Affairs
- Knowledge of the latest technical and regulatory developments

**Why AstraZeneca?**
- At AstraZeneca we’re d