Area Lead/Specialist Safety Point of Contact (SPoC)

Job description

Details:

***Please note this is a PT position, 3 days/week totaling 22.5hrs***

The Role supports GMs, Area Medical Lead and CH Head of Safety to ensure delivery of Pharmacovigilance (PV) as per PV Shared Service Agreement (SSAs) in Canada. 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 (Local Operating Companies) 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 Named Safety Contact (NSC) to ensure activities are being conducted as per agreement.
• Support GMs and Area Medical Lead in the PV SSA negotiation and renewal.

PRIMARY RESPONSIBILITIES
General
• Working as part of the Area Medical Affairs team and Central Safety in development of a Culture of High Performance and quality.

Safety/Compliance implementation
• 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
o Interative Digital Media, Market Research, Patient Support Programs (ChimAERa)
o Handling third party deals
• 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 (CH) business and data collection for internal and external inspections.
• Ensure compliance of Regulatory responsibilities for safety-related activities such as:
• Support in collecting Periodic Safety Update Report/Periodic Benefit Risk Evaluation Report (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 Person Responsible for Pharmacovigilance/Named Safety Contact (PRP/NSC) on country specific Product Incident Review Committee (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 is an equal opportunity employer committed to diversity and inclusion. We welcome applications from all qualified individuals. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at ************@*******.**

Contact information:

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Desired profile

Basic qualifications:

***Please note this is a PT position, 3 days/week totaling 22.5hrs***

• BSc level degree in Biomedical sciences specializing in Pharmacovigilance, Safety or related scientific field
• Minimum 3-4 years experience in the Pharmaceutical or Healthcare industry, preferably in a Pharmaceutical/ Consumer Healthcare / FMCH with safety or pharmacovigilance experience for the Lead role. Minimum 1-2 years experience for the Specialist role.
• Strong judgment and analytical skills; ability to work independently and drive performance standards
• Strong verbal and written communication skills in English/ other local required languages.
• Strong computer literacy including competence in Microsoft Office software.
• The ability to build and maintains trusting relationships within and beyond their team.
• The ability to engage constructively with others and demonstrate a positive mindset.
• The ability to hold themselves and others accountable for delivering quality results.

Preferred qualifications:

***Please note this is a PT position, 3 days/week totaling 22.5hrs***

• Medical/Scientific professional qualification preferred