Marketed Product Safety Specialist 2

2 weeks ago


Kuala Lumpur, Kuala Lumpur, Malaysia Novasyte Full time

Responsibilities:

  • Act as the local Qualified Person in accordance with requirements set out in IQVIA Lifecycle Safety Regulatory Intelligence Database (RID).
  • Availability on a 24/7 basis to receive calls from the local Competent Authority as required. Act as the contact point for pharmacovigilance inspections. Deal directly with the Competent Authority inspectors during statutory inspections.
  • Respond fully and promptly to requests from Competent Authorities to evaluate the benefits and risks of a medicinal product to include information regarding sales or prescriptions or postauthorization of safety studies of medicinal l products.
  • Verifies that his/her name and contact details have been notified to the Competent Authority upon contract commencement.
  • Remain up to date and aware of any changes in local regulatory requirements; verifies the necessary mechanisms and regulatory measures adopted for safety reasons and the risk management plans are carried out.
  • Establish and maintain a thorough understanding of each project's budget and scope of work (SOW); set up and maintain project materials such as project files, forms, templates, databases and workflow.
  • Deal directly with the Competent Authority and undergo questioning by regulatory authority inspectors during statutory inspections.
  • Provide regular reports to project manager on project metrics, SOW changes, customer requests or concerns.
  • Communicate regular monthly updates to the EU QPPV/designee & complete regulatory reports as required.

Requirements:

  • Bachelor's degree in a lifescience, medicine, pharmacy or nursing or educational equivalent.
  • Around 4 years relevant clinical experience including experience managing clinical trial safety/postmarketing safety; or equivalent combination of education, training and experience.
  • Resident in Malaysia with fluent Bahasa Malaysia skills & excellent command of the English language
  • Indepth knowledge of applicable global, regional and local regulatory requirements; and International Conference on Harmonization (ICH) guidelines.
  • Excellent knowledge of the pharmacovigilance legal framework in the EU and in Malaysia.
  • Solid knowledge of relevant Standard Operating Procedures (SOPs).
  • Possess excellent written and verbal communication skills.
  • Excellent analytical and problemsolving approach when interpreting safety reports, literature and undergoing inspections.
  • Strong organizational and project management skills
  • Ability to establish and maintain effective working relationships with coworkers, managers, customers and third parties
  • Maintain an overview of the safety profile of the product and factors that may affect the benefit/risk balance of a product
  • Demonstrate an understanding of compliance and of quality management systems
  • Availability by phone 24/7 for Competent Authority inquiries
  • May require some travel


IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry.

We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.

Learn more at
  • Product Safety

    2 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia BASF Asia-Pacific Service Centre Sdn. Bhd. Full time

    _Do you want to work with passionate teams, providing excellent business and digital services to the Asia Pacific region? __Do you want an open, supportive, and caring working environment?__ Do you view your development needs seriously as we do?__ If YES, then take your career to the #NextLevel with BASF _DescriptionProduct Safety Asia Pacific is an...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Expro Full time

    Who is Expro?Working for our clients across the entire well life cycle, Expro is a visionary full-cycle energy services expert offering novel, insightful solutions, dependable competency and award-winning safety.Combining innovative, future-facing technology with high-quality data across well construction, well flow management and production, subsea well...

  • Product Safety

    1 month ago


    Kuala Lumpur, Kuala Lumpur, Malaysia BASF SE Full time

    Do you want to work with passionate teams, providing excellent business and digital services to the Asia Pacific region? Do you want an open, supportive, and caring working environment?Do you view your development needs seriously as we do?If YES, then take your career to the #NextLevel with BASF Description Product Safety Asia Pacific is an integrated...

  • Product Safety

    4 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia BASF SE Full time

    Do you want to work with passionate teams, providing excellent business and digital services to the Asia Pacific region? Do you want an open, supportive, and caring working environment?Do you view your development needs seriously as we do?If YES, then take your career to the #NextLevel with BASF Description Product Safety Asia Pacific is an integrated...


  • Kuala Lumpur, Kuala Lumpur, Malaysia TIME's Group Full time

    Specialist, Product Marketing (Prepaid Marketing) Product Management & Development (Marketing & Communications) Life at U Mobile We are Passionate, Innovative, Trustworthy, Team-Oriented & Fun-Loving. At U Mobile, we are always on the lookout for great talents and passionate individuals to join our growing team. Let's start your journey with an award-winning...

  • Product Safety

    2 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia Henkel Full time

    At Henkel, you can build on a strong legacy and leading positions in both industrial and consumer businesses to reimagine and improve life every day. If you love challenging the status quo, join our community of over 50,000 pioneers around the globe. Our teams at Henkel Adhesive Technologies help to transform entire industries and provide our customers with...

  • Product Specialist

    2 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia Park@City Pharmacy Sdn Bhd Full time

    As a Product Specialist with Avelon, you'll be support marketing initiatives by travelling to multiple retail locations, conducting on-ground retail sales research, provide training to retail salesperson, and assisting in the development of marketing campaigns to promote health and wellness products/services. Gain practical experience in nutrition marketing...

  • Product Specialist

    2 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia Rxilient Health Malaysia Sdn Bhd Full time

    Promote and sell the company's products to healthcare professionals such as doctors, nurses, and pharmacists. Organize and execute sales presentations to medical groups and healthcare facilities. Understand and convey complex medical information to healthcare professionals and patients. Develop and maintain relationships with healthcare providers and ensure...

  • Product Specialist

    2 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia iHEAL Medical Centre Full time

    Join our team.Please send your resume/CV to:Product Specialist QualificationBachelor's Degree, Post Graduate Diploma, Professional Degree Requirements2 years experience in related field


  • Kuala Lumpur, Kuala Lumpur, Malaysia StoreHub Full time

    Are you driven, results-oriented and a team player?With 15,000 customers in over 15 countries, StoreHub's mission is to make business awesome for everyone by providing retail and restaurant businesses the technology and services they need to succeed.At StoreHub, we believe that technology is essential for businesses to survive and thrive in today's...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Perdana University Full time

    Marketing Communications Specialist job briefOur company is looking for a talented and highly motivated Marketing Communications Specialist to join our team. As a Marketing Communications Specialist, you will be responsible for creating and executing marketing campaigns that effectively promote our brand and products. You will work closely with other members...

  • Product Specialist

    2 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia Pharma Nord Sdn Bhd Full time

    Good to announce that we are hiring for Product Specialist position - base in:Kuala Lumpur (Q-Sentral)Job Description:Are you driven, optimistic and ready to take on new challenges?We are looking for Product Specialists with a growth mindset to connect our brand with our key audiences. To help you succeed in this role, product training and sales coaching...


  • Kuala Lumpur, Kuala Lumpur, Malaysia Novasyte Full time

    As our business grows, we are looking to further strengthen our Medical Information & Pharmacovigilance team by hiring Drug Safety Operations Coordinator/Specialist in IQVIA Malaysia.As part of the Safety Operations team, you will provide data gathering, entry, and reporting services on behalf of contracted customers, including both clinical trial and...

  • Product Specialist

    2 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia Pharma Nord Sdn Bhd Full time

    Good to announce that we are hiring for PRODUCT SPECIALIST position - base in:KUALA LUMPUR:- MALACCA:- JOHOR BHARUAre you driven, optimistic and ready to take on new challenges?We are looking for Product Specialists with a growth mindset to connect our brand with our key audiences. To help you succeed in this role, product training and sales coaching will be...

  • Product Specialist

    2 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia EPS Ventures Sdn Bhd Full time

    Area of coverage will be in Central/Penang/PerakJOB DESCRIPTION Responsible for the achievement of the assigned territory's Sales Budget Maintain, cultivate and expand existing customers in line with the Company's growth strategies Organize and conduct CME (Continuing Medical Education) activities to promote the specific product assigned Maintain an updated...

  • Product Specialist

    2 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia ConvaTec Full time

    Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services...

  • Production Specialist

    2 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia Texas Instruments Full time

    About TITexas Instruments Incorporated (TI) is a global semiconductor design and manufacturing company that develops analog ICs and embedded processors. By employing the world's brightest minds, TI creates innovations that shape the future of technology. TI is helping about 100,000 customers transform the future, today. We're committed to building a better...

  • Marketing Specialist

    2 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia GENO Management Full time

    Position : Marketing SpecialistSalary : RM 3,400 - RM 3,700Working Hours : 9.00am - 6.00pmLocation : Petaling JayaJob Scope Create and support the daytoday execution of ad campaigns across Facebook and Google Ads platforms, including ad copy, creative assets, targeting, optimisation and budget management, to achieve departmental KPIs. Own the optimization...

  • Product Safety

    4 weeks ago


    Kuala Lumpur, Kuala Lumpur, Malaysia BASF SE Full time

    We are a leading chemical company, with the best teams developing intelligent solutions for our customers, and for a sustainable future. We connect and develop people with diverse talents all over the world. For you, this means a variety of ways to progress. Not only your performance but also your personality matter to us, regardless of gender, age,...

  • Product Safety

    1 month ago


    Kuala Lumpur, Kuala Lumpur, Malaysia BASF SE Full time

    We are a leading chemical company, with the best teams developing intelligent solutions for our customers, and for a sustainable future. We connect and develop people with diverse talents all over the world. For you, this means a variety of ways to progress. Not only your performance but also your personality matter to us, regardless of gender, age,...