Your Responsibilities:

The purpose of this role is to support delivery of pharmacovigilance in CH Local Operating Companies. The Area SPoC role is LOC cost and HC to report locally & operationally to CH Area Medical Lead with dotted line to CH Head of Safety/Affiliate Liaison. The person will be located at Area level.

The role will regularly liaise with Pharma NSCs, PRPs and relevant stakeholders (i.e.Business leads) to ensure PV related activities, periodic meetings and reports are submitted in a timely manner and with the required quality.

The Role supports GMs, Area Medical Lead and CH Head of Safety to ensure delivery of Pharmacovigilance as per PV SSAs in all countries in the corresponding area. The Area CH Safety PoC will ensure compliance with the PV SSA which includes but is not limited to:

• Lead annual review and update of all PV SSAs of the corresponding area and facilitate the management of the PV SSA with Pharma.
• Update the CH General Managers and CH Head of Drug Safety or delegate on the status of the LOC PV system (e.g., Quarterly Pharmacovigilance reports (QPV report)), expedite notification of any PV issue(s) that may impact the CH business, and provide periodic reports on activities covered on the PV SSA for each GM in the Area.
• Lead regular meetings with the NSC to ensure activities are being conducted as per agreement.
• Support GMs and Area Medical Lead in the PV SSA negotiation and renewal.

Key Responsibilities:

• Working as part of the Area Medical Affairs team and Central Safety in development of a Culture of High Performance and quality.
• Perform an annual review of the PV SSAs (or more frequently if required) with the corresponding NSC and request a new version is signed off by the GMs and agreed with appropriate staff, even when there has been no change.
• Ensure that the PV activities retained by CH under the PV SSA have been discussed and agreed with the CH responsible person executing the activity, the CH Head of Safety or delegate and the CH Area Lead.
• Define the list of local Journals for AE monitoring for CH products. Communicate the list with Pharma and ensure monitoring of these journals for AEs.
• Agree with the NSC the corrective actions and owners to mitigate PV risks identified from different sources (e.g., risk assessment questionnaires, Management Monitoring, Independent Business Monitoring and/or Independent Assurance).
• Promptly inform the NSCs of any deviations, issues or risks identified for the PV activities retained by CH.
• Liaise with different business owners to ensure appropriate implementation of relevant processes that impact PV tasks as covered in the PV SSA:

o Handling of Product Complaints

o Medical Information (Ensure Medical Information process captures PV requirements as per SOP-CHC-409)

o Interative Digital Media, Market Research, Patient Support Programs (ChimAERa)

o Handling third party deals as per SOP- GSKF- 012

• Ensure all required CH reports (such as quality complaint sheet, Medical Information log, etc) required for AE reconciliations executed by the NSC are submitted to the NSC as per the planned schedule. Support the NSCs when issues are identified in this process.
• Support NSC for audits on Consumer Healthcare business and data collection for internal and external inspections.
• Ensure compliance of Regulatory responsibilities for safety-related activities such as:
• Support in collecting PSUR/PBRER related sales data and safety action in timely manner on country level unless this is agreed to be managed by NSC.
• Ensure an updated list of Consumer Healthcare products covered by this agreement, including the local acquisitions.
• Ensure appropriate implementation of label changes.
• Update PRP/NSC on country specific PIRC/LIC and safety related action.
• Sending periodic reports (e.g. PBRERS) to the local regulatory authority on country level (in some countries as applicable) unless this is agreed to be managed by NSC or Regulatory.
• Ensuring there is a process to keep the product label updated for products with no PV central support.
• Identify the local Products with no PV central support and alert central safety and Area Medical Leads for the needed safety actions such as signal detection process, PSURs or any other local safety report required by local regulations.
• Manage DHCP letter process in CH LOC.
• Manage oversight of Risk Management Plan process and implementing in the LOC.
• Support NSC and/or HR to ensure implementation of PV training for new starters.

GSK's dedication to the wellbeing of our employees is reflected in the benefits we offer; including healthcare for yourself and dependents, performance related bonus, long term incentives and a host of other flexible offerings you can tailor to your own preferences. We also offer a range of employee health and wellbeing programs including our truly unique Partnership for Prevention program, a global commitment by GSK to provide all employees with up to 40 preventative healthcare services bringing to life our mission to: do more, feel better and live longer.

At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.

If you would like to join us in innovating and inspiring changes in the industry, we urge you to apply by 30 July 2019.

*LI-GSK

Why You?Basic qualifications:

• 3-4 years experience in the Pharmaceutical or Healthcare industry, preferably in a Pharmaceutical/ Consumer Healthcare / FMCH with safety or pharmacovigilance experience.

Preferred qualifications:

As above

Why GSK?:

GlaxoSmithKline (GSK) is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. We have three global businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products. Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies.

We are proud of the difference we make. GSK has ranked 1st in the Access to Medicines Index all five times since its launch in 2008 and FORTUNE Magazine ranked us #1 on its 'Change the World list' which recognises companies that have made significant progress in sustainable, scalable approaches to addressing societal problems as part of their company strategy.

GSK has been present in Asia for over 50 years and our commitment to the region is strengthened by the establishment of our purpose-built headquarters for Asia. Situated in Singapore, GSK Asia House is a further step in our long-standing strategy to grow and diversify our company - emphasizing the globally balanced business we have built over the years. To better support Asia, we focus on developing talent to improve our ability to make the right decisions for healthcare professionals, patients and consumers across the region.

Contact information:

You may apply for this position online by selecting the Apply now button.

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