Job Description

Are you energized by a highly visible safety role that ensures the accuracy of critical safety data? If so, this Regional Pharmacovigilance Specialist role could be an ideal opportunity to explore!

As a Regional Pharmacovigilance Specialist, you will be responsible for conducting day to day management of pharmacovigilance activities for Consumer Healthcare marketed products and products under development in Indonesia, Malaysia, Singapore and Brunei. This includes ensuring compliance with all local regulations and GSK global requirements respectively in terms of pharmacovigilance, materiovigilance, cosmetovigilance and nutrivigilance. In addition, this role will also has the exposure to support the APAC Quality and Oversight Manager in maintaining compliance metrics for the APAC territory including distribution markets. Act as backup of the Consumer Safety Leads for ANZ (Australia and New Zealand), SEAT (South-East Asia and Taiwan) and ISC (Indian Subcontinental Countries).

This position is open for 2 years contract.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

1. Ensure compliance with company, industry and regulatory authority laws, regulations and standards, etc in the responsible territories: Indonesia, Malaysia, Singapore and Brunei. Coordinate to develop and implement relevant PV initiatives and plans.

2. Responsible for day to day management of Pharmacovigilance (PV), Materiovigilance, Cosmetovigilance and Nutrivigilance activities for responsible territories including the following:

• Safety reporting, support all safety matters/activities related to GSK Consumer Healthcare marketed products and investigational products in clinical trials in accordance with internal processes and international and local regulatory requirements and guidelines
• Provide Pharmacovigilance support and ensure training in Human Safety Information reporting to all GSK employees and relevant third party staff
• Provide consultation and Human Safety Information/Adverse Event clause for contracts/agreements other than SDEAs; Negotiates Safety Data Exchange procedures for local licensing agreements in conjunction with required stakeholders such as Deal Lead, Legal and Regulatory Affairs
• Perform due diligence of PV system for new local licensing partners
• Ensure Human Safety Information reporting compliance in local commercial activities, including Digital activities, Market Research and Patient Support Program; provide PV support to business owners who operate these activities.
• Ensure appropriate management monitoring of PV activities for Consumer Health Products
• Identify new or changes to existing laws, regulations or standards relating to Pharmacovigilance (PV), Materiovigilance, Cosmetovigilance and Nutrivigilance

3. Support APAC Quality and Oversight Manager in maintaining compliance metrics for APAC territory including distribution markets.

4. Act as backup of the Consumer Safety Leads for ANZ (Australia and New Zealand), SEAT (South-East Asia and Taiwan) and ISC (Indian Subcontinental Countries) to ensure business continuity.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelor’s degree with major in pharmaceutical related disciplines (e.g. pharmacology, biochemistry etc.)
• At least 3-5 years of local or regional Pharmacovigilance experience in pharmaceutical companies
• Good understanding of regulatory environment and Knowledge of global Pharmacovigilance Conventions
• Familiar with local Pharmacovigilance regulations and ICH guidelines

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Good communication skills
• Fluent in English speaking/writing
• Agile and target driven mindset
• Good team player
• Proactive and collaborative characters

Why GSK?

Our values and expectations are at the heart of everything we do and form an important part of our culture.

These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:

• Operating at pace and agile decision-making – using evidence and applying judgement to balance pace, rigour and risk.
• Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
• Continuously looking for opportunities to learn, build skills and share learning.
• Sustaining energy and well-being
• Building strong relationships and collaboration, honest and open conversations.
• Budgeting and cost-consciousness

• LI-GSK

Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.

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