Regulatory Affairs/ Pharmacovigilance Executive

Regulatory Affairs/ Pharmacovigilance Executive-2011993



OUR COMPANY
At Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.


THE POSITION
This position is responsible for handling the product registration chain, compliance with regulatory authorities and ROPU/Global Regulatory Affairs (RA), maintenance of product licenses, and relevant LCM (life cycle management) activities; and the Pharmacovigilance (PV) system in compliance with local regulations and ROPU / Global PV guidance.
The position functions as the link with all distributor RA team in MYSG. It provides support in the execution of RA tasks in MYSG. The position is responsible for the planning and executing of the products registration process or Regulatory Affairs activities align with technical team in the MYSG including processing PV cases, ensuring distributor staff PV training, production of local aggregated PV reports, managing PV related contracts, and identifying/ communicating PV signals.



Duties & Responsibilities
Regulatory Affairs
Support preparation of original dossiers for submission in MYSG in registration of AH products. Together with the ROPU RA, prepare dossiers and documents for all renewal and variation activities for BIAH MYS
Responsible for maintaining and updating the MYSG RA databases (e.g. WPPS, CPD3, BIRDS, TAPAs, DAVID)
Prepare, Review and dispatch the registration dossier to distributor including new registrations and variations.
Maintenance all product registration certificates.
Develop/maintain relationship with relevant internal and external parties to expedite the registration process.
Ensure regulatory compliance through the entire process
Provide regulatory input to support sales team in terms of technical information and compliance aspects
Management of information and regulatory dossiers in order to ensure confidentiality, information protection and agility to provide information.
Initiate and drive communication with distributors and technical personals for product registration.
Drive and share best practice in RA
Training of distributor RA team to ensure high quality output
Pharmacovigilance
Monitors and improves OPU PV data collection and reporting system. Ensures correctness, completeness and reliability of PV information. Enters Adverse Event Reports (AERs) into Global PV data base
Provide input to RA/PV internal system (e.g. WPPS, CPD3, BIRDS, TAPAs). Provide input to Adverse Event Reports (AERs) into Global PV data base;
Conduct PV training to distributor and BI internal team.
Requirements
Bachelor’s degree in sciences such as animal husbandry, pharmacy, animal science, biotechnology, veterinary medicine or any related fields is required.
2 – 3 years’ experience in pharmaceutical or animal health industry especially in Regulatory Affairs / Pharmacovigilence is preferred.
Fresh graduates with science degrees are welcome to apply.
Good analytical, communication and interpersonal skills.
Computer literate - MS Word, Excel, PowerPoint




WHY BOEHRINGER INGELHEIM?
With us, you can grow, collaborate, innovate and improve lives.
We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices. In addition, learning and development for all employees is key, because your growth is our growth.



We also offer competitive salary, attractive health plans and numerous benefits and rewards. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.



Want to learn more? Visit https://www.boehringer-ingelheim.com/



READY TO CONTACT US?
Please contact our Recruiting SEASK Recruiting Team



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POSITION AREA
Regulatory Affairs & Pharmacovigilance, AH
POSITION LOCATION
Malaysia
ORGANIZATION
Boehringer Ingelheim (Malaysia) Sdn Bhd
Schedule
Full Time




Job - Marketing

Primary Location - Africa, Asia, Australasia-Malaysia

Organization - MY-Boehringer Ingelheim (Malaysia) Sdn. Bhd

Schedule - Full-time

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