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Regulatory Pharmacist

Location Kfar Saba, Central District, Israel Job ID R-110911 Date posted 13/06/2021

We’re always looking for someone different to join our efficient and nimble team. If you can offer us some original thinking, a different approach or skillset, then you’ll fit in. Confident in stepping up and taking accountability, we showcase what Regulatory can do around the business.

Trusted and respected, we’re often called upon to provide input in shaping drug development strategy across all levels of the business. We’re part of the solution, involved in key discussions, in our role we act as both a drug developer and Regulator. We think broadly about patients and what it takes to prevent and treat diseases to develop progressive solutions. Our science-driven approach means our Regulatory strategy is even more appreciated and valued. Here we get to be part of the solution, bringing life-changing medicines to patients.

AstraZeneca’s Kfar Saba offices is the home of our local Israel business. It’s where business, regulatory, medical and enabling units integral to our strategy are based and where 140 of our colleagues innovate for a higher purpose. Our new offices offer an open floor plan to allow cross-functional collaboration and encourage innovation.

Typical Accountabilities:

Product registration & file maintenance

  • Preparation of registration files (with the support and supervision of the appointed pharmacists) . In the content and structure of the CTD according to the requirements of the ICH, and in accordance with the regulatory requirements of the Israeli Ministry of Health, and in accordance with the policies and procedures of AstraZeneca.
  • Preparation of packaging materials of the company's systems and

Registration

  • Preparation of registration files in all areas of registration; new drug applications, clinical changes and change in the quality chapter, leaflet updates and any regulatory activity as  required according to the local regulations and AstraZeneca policies and guidelines.
  • Documentation and follow-up for all registration activities in accordance with the company's requirements,
  • Updating registration data in the company's local and global systems
  • Update the actions required after receiving approval from the Ministry of Health for new submissions and quality changes.
  • The work processes will be carried out in accordance with the requirements of the company's quality system and the GRP standard
  • Preparation of packaging materials
  • Handling and monitoring the preparation of the packaging processes in the company's systems.
  • The work will be carried out in accordance with the GMP standard, in accordance with the requirements of the Ministry of Health in Israel - relevant procedures, the company's quality standards and the AstraZeneca Israel procedure.

Pharmacovigilance

Deputy to Patient Safety Manager

Ensures compliance with both AZ requirements and global and local regulatory requirements for patient safety and ensures corrective and preventative actions are taken in the event of local noncompliance. Ensures that all local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF).

Ensures that up-to-date Organisation charts, job descriptions, training records and curriculum vitae are available for the local Patient Safety personnel.

Maintains oversight of all safety related processes, issues and brand activities within their country

Ensures that an after-hours process is in place, to ensure a customer can report an adverse event, to respond to regulatory authority questions, to facilitate local health authority unscheduled inspections, and to facilitate the un-blinding of local studies if that has been agreed as a local safety responsibility.

Ensures that appropriate cover is in place so that all activities continue to be performed within the required timeframes when the patient safety manager is out of the office, on holiday, unexpected leave etc.

Maintains an in-depth knowledge of their local authority; the regulations, expectations and

regulatory authority contacts and confirms local reporting requirements at not less than 3 monthly intervals, ensuring that global Patient Safety is notified of any changes in regulatory requirements immediately.

Maintains current knowledge of the marketed status of products in their local country and

reference documents such Summary of Product Characteristics or other local market data sheet Possesses working knowledge of applicable procedural documents as well as knowledge of AstraZeneca products sufficient to enable training and annual refresher training of all local staff and locally engaged vendors, in safety processes and procedures

Ensures that when transfer of pharmacovigilance data occurs within an Organisation or between organizations, the mechanism should be such that there is confidence that all notifications are received and that a confirmation and/or reconciliation process should be undertaken.

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.

Ensures that local processes, procedures and systems are in place for recording, processing,

following up and translation of AEs from spontaneous and solicited sources, AEs from local noninterventional studies and SAEs from local interventional clinical studies

Ensures that local regulatory requirements are defined with respect to reporting ICSRs to local Health Authorities, local ethics committees and investigators (including when the clinical distribution hub is used) and ensures that these reports are tracked (tracking conducted by clinical hub when used), so that details of when a report was issued and to whom, are available.

Ensures that local processes are in place with respect to submission and tracking of periodic safety reports to local Health Authorities, investigators and ethics committees

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

Reviews local language medical or scientific literature to identify possible case reports, and

forwards in a timely manner to the AZ Patient Safety Data Entry Site.

Ensures that the relevant global patient safety is notified of potential safety signals and issues and any unsolicited reports of unexpected benefit occurring with Approved Products are forwarded to the Data Entry Site and the global patient safety.

Ensures that the local legal team are informed of threatened, possible or actual legal action

Ensures a local Business Continuity Process for Patient Safety is in place and tested at least annually.

Essential Requirements

  • Bachelors degree in related discipline
  • Pharmacist with a valid Ministry of Health license to practice pharmacy
  • experience in the field of registration
  • Good command of spoken and written English
  • Good communication & ability to collaborate effectively across functions
  • Solid scientific understanding
  • Proven ability of interacting with stakeholders
  • Proven ability to learn the different TAs from various perspectives,
  • Proven ability to communicate in a matrix matter with different functions both internally and externally
  • Accurate and result oriented, Punctual, meticulous
  • Ability to work under pressure without compromising on results
  • High ethical standards
  • High command of the English language – spoken & written
  • High level of computer knowledge

Desirable

  • Experience in product registration including artwork creation (packaging)
  • Experience in Pharmacovigilance  
  • Knowledge and experience in Managing Quality System is a preference
  • Certified as Qualified Person by the Israeli Ministry of

Where can I find out more?

Please visit us at: https://www.astrazeneca.com/country-sites/israel.html

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

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

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 fill free to share this posting with them.

If you would like to be notified about future job opportunities, you can set up a job alert!  Sign up on our Careers site and Manage your job alerts.

We’re always looking for someone different to join our efficient and nimble team. If you can offer us some original thinking, a different approach or skillset, then you’ll fit in. Confident in stepping up and taking accountability, we showcase what Regulatory can do around the business.

Trusted and respected, we’re often called upon to provide input in shaping drug development strategy across all levels of the business. We’re part of the solution, involved in key discussions, in our role we act as both a drug developer and Regulator. We think broadly about patients and what it takes to prevent and treat diseases to develop progressive solutions. Our science-driven approach means our Regulatory strategy is even more appreciated and valued. Here we get to be part of the solution, bringing life-changing medicines to patients.

AstraZeneca’s Kfar Saba offices is the home of our local Israel business. It’s where business, regulatory, medical and enabling units integral to our strategy are based and where 140 of our colleagues innovate for a higher purpose. Our new offices offer an open floor plan to allow cross-functional collaboration and encourage innovation.

Typical Accountabilities:

Product registration & file maintenance

  • Preparation of registration files (with the support and supervision of the appointed pharmacists) . In the content and structure of the CTD according to the requirements of the ICH, and in accordance with the regulatory requirements of the Israeli Ministry of Health, and in accordance with the policies and procedures of AstraZeneca.
  • Preparation of packaging materials of the company's systems and

Registration

  • Preparation of registration files in all areas of registration; new drug applications, clinical changes and change in the quality chapter, leaflet updates and any regulatory activity as  required according to the local regulations and AstraZeneca policies and guidelines.
  • Documentation and follow-up for all registration activities in accordance with the company's requirements,
  • Updating registration data in the company's local and global systems
  • Update the actions required after receiving approval from the Ministry of Health for new submissions and quality changes.
  • The work processes will be carried out in accordance with the requirements of the company's quality system and the GRP standard
  • Preparation of packaging materials
  • Handling and monitoring the preparation of the packaging processes in the company's systems.
  • The work will be carried out in accordance with the GMP standard, in accordance with the requirements of the Ministry of Health in Israel - relevant procedures, the company's quality standards and the AstraZeneca Israel procedure.

Pharmacovigilance

Deputy to Patient Safety Manager

Ensures compliance with both AZ requirements and global and local regulatory requirements for patient safety and ensures corrective and preventative actions are taken in the event of local noncompliance. Ensures that all local information relating to pharmacovigilance activities is reflected correctly in the Pharmacovigilance System Master File (PSMF).

Ensures that up-to-date Organisation charts, job descriptions, training records and curriculum vitae are available for the local Patient Safety personnel.

Maintains oversight of all safety related processes, issues and brand activities within their country

Ensures that an after-hours process is in place, to ensure a customer can report an adverse event, to respond to regulatory authority questions, to facilitate local health authority unscheduled inspections, and to facilitate the un-blinding of local studies if that has been agreed as a local safety responsibility.

Ensures that appropriate cover is in place so that all activities continue to be performed within the required timeframes when the patient safety manager is out of the office, on holiday, unexpected leave etc.

Maintains an in-depth knowledge of their local authority; the regulations, expectations and

regulatory authority contacts and confirms local reporting requirements at not less than 3 monthly intervals, ensuring that global Patient Safety is notified of any changes in regulatory requirements immediately.

Maintains current knowledge of the marketed status of products in their local country and

reference documents such Summary of Product Characteristics or other local market data sheet Possesses working knowledge of applicable procedural documents as well as knowledge of AstraZeneca products sufficient to enable training and annual refresher training of all local staff and locally engaged vendors, in safety processes and procedures

Ensures that when transfer of pharmacovigilance data occurs within an Organisation or between organizations, the mechanism should be such that there is confidence that all notifications are received and that a confirmation and/or reconciliation process should be undertaken.

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.

Ensures that local processes, procedures and systems are in place for recording, processing,

following up and translation of AEs from spontaneous and solicited sources, AEs from local noninterventional studies and SAEs from local interventional clinical studies

Ensures that local regulatory requirements are defined with respect to reporting ICSRs to local Health Authorities, local ethics committees and investigators (including when the clinical distribution hub is used) and ensures that these reports are tracked (tracking conducted by clinical hub when used), so that details of when a report was issued and to whom, are available.

Ensures that local processes are in place with respect to submission and tracking of periodic safety reports to local Health Authorities, investigators and ethics committees

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

Reviews local language medical or scientific literature to identify possible case reports, and

forwards in a timely manner to the AZ Patient Safety Data Entry Site.

Ensures that the relevant global patient safety is notified of potential safety signals and issues and any unsolicited reports of unexpected benefit occurring with Approved Products are forwarded to the Data Entry Site and the global patient safety.

Ensures that the local legal team are informed of threatened, possible or actual legal action

Ensures a local Business Continuity Process for Patient Safety is in place and tested at least annually.

Essential Requirements

  • Bachelors degree in related discipline
  • Pharmacist with a valid Ministry of Health license to practice pharmacy
  • experience in the field of registration
  • Good command of spoken and written English
  • Good communication & ability to collaborate effectively across functions
  • Solid scientific understanding
  • Proven ability of interacting with stakeholders
  • Proven ability to learn the different TAs from various perspectives,
  • Proven ability to communicate in a matrix matter with different functions both internally and externally
  • Accurate and result oriented, Punctual, meticulous
  • Ability to work under pressure without compromising on results
  • High ethical standards
  • High command of the English language – spoken & written
  • High level of computer knowledge

Desirable

  • Experience in product registration including artwork creation (packaging)
  • Experience in Pharmacovigilance  
  • Knowledge and experience in Managing Quality System is a preference
  • Certified as Qualified Person by the Israeli Ministry of

Where can I find out more?

Please visit us at: https://www.astrazeneca.com/country-sites/israel.html

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

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

Follow AstraZeneca on Instagram https://www.instagram.com/astrazeneca_careers/?hl=en

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 fill free to share this posting with them.

If you would like to be notified about future job opportunities, you can set up a job alert!  Sign up on our Careers site and Manage your job alerts.



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.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.