(Associate-) Director Safety Operations Officer APAC

 

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(Associate-) Director Safety Operations Officer APAC 

 


 

 

As Local Safety Officer* APAC you are working within the Safety Operations & Regions team of the Medical Safety and Pharmacovigilance (MSPv)department.

 

Your main responsibilities are: 

  • Be the contact for Safety Operations & Regions for activities in the territory of APAC in liaison between MSPv and various local stakeholders on various pharmacovigilance activities; 
  • Assist with the preparation and submission of IND and clinical trial applications, safety aspects of MAA and NDA to the regulatory authority for the territory of APAC; 
  • Where applicable, oversee and ensure implementation of risk mitigation requirements for locally marketed products, including but not limited to (additional) risk mitigation actions and product recalls, in close collaboration with global functions and, where applicable, with BioNTech's partners and vendors;
  • Responsible for the completeness and accuracy of submission tracking records for post-approval commitments and their milestones; 
  • Accountable for implementation of appropriate measures to ensure compliance with the applicable laws and regulations concerning personal data privacy legislation; 
  • Support and ensure case processing and reporting of ICSRs/SUSARs and aggregate safety reports to regulatory authority in APAC region, where applicable
  • Support Data transfer activities in compliance with regulatory requirements
  • Perform regular reconciliation/compliance activities for ICSR exchange with BioNTech Partners and/or vendor;
  • Develop and implement local pharmacovigilance-related procedural documents in accordance with global/company policies and with local regulatory requirements;
  • Support the Head of Regions & Safety Operations in the preparation and maintenance of pharmaco-vigilance agreements/safety data exchange agreements with local partners, and vendors;

 

 

What you have to offer.

  • Several years of experience in pharmacovigilance and product safety within the pharmaceutical industry; 
  • Expert knowledge of local pharmacovigilance regulatory requirements and processes; 
  • Experience in managing the local pharmacovigilance system, including but not limited to case handling and pharmacovigilance documentation;
  • Fulfillment of local pharmacovigilance officer responsibilities 
  • Experience in preparing for and responding to regulatory audits and inspections; 
  • Experience in clinical trial safety management according to ICH standards. 
  • Ability to interact/cooperate with other departments, partners, third parties and vendors;
  • Fluency in written and spoken English and Chinese language;
  • Experience with formal regulatory and legal language documents; 
  • Excellent communication skills 
  • Experience with standard business software (Word, Excel, Power Point) and pharmacovigilance database systems.

 


 

Benefits for you:

 

  • Flexible Working Time
  • Mobile Office
  • Work from EU Countries (up to 20 days per year)
  • Company Pension Scheme
  • Childcare
  • Jobticket
  • Company Bike
  • Leave Account
  • Fitness Courses
     

... and much more.
 

 

Have we kindled your pioneering spirit? 

 

Then apply now for our location Mainz K1 and simply send us your application documents using our online form.

If you have any further questions, our Talent Acquisition Team will be happy to answer them on + 49 (0) 6131-9084-1291 (monday-friday, from 12 noon to 4 pm).

Job-ID 6465 (please indicate for inquiries)

We look forward to your application!

*BioNTech does not tolerate discrimination, favoritism, or harassment based on gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important – it’s a match!

BioNTech - As unique as you

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