Site Name: USA - Maryland - Rockville
Posted Date: Jun 2 2020
Are you looking for a high-profile safety role that ensures the accuracy of critical safety data across multiple geographies? If so, this Safety Pharmacovigilance Manager role could be an ideal opportunity to explore.
As a Safety Pharmacovigilance Manager, you will manage the set-up, handover, and oversight of the Pharmacovigilance (PV) Hub’s various country requirements, ensuring high PV standards and following regulatory mandated requirements across designated country clusters. You will be responsible to ensure there is close alignment with respective General Managers (GMs) to ensure governance requirements.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Responsible for day to day management of Adverse Event (AE), incident and pregnancy reports for all countries within the Hub.
Accountable for exchange of safety data with licensing partners and maintenance of report files for local Safety Data Exchange (SDE) agreements as necessary.
Responsible for fulfilling local regulation for reporting to local regulatory authorities within mandated timeframes for expedited reports.
Ensure relevant training to authorized external third parties and internal stakeholders on literature review purposes, adverse event reporting, and medical information queries.
Notify CSD of any new GSK sponsored external facing websites that include free text facility.
Ensure a process is in place to identify and process AEs from websites including additional responsibility for medical information processes within the assigned country clusters.
Monitor locally published medical and scientific literature to identify reports which may not have been indexed on commercial or internal literature databases and for documenting the local literature review monthly.
Ensure there is an established process for liaison with the relevant departments dealing with product complaints and medical enquiries (in all countries).
Regular review of local product complaint log to ensure that AE, incident or pregnancy information reported in association with a product complaint or medical enquiry is notified to the Named Safety Contact (NSC).
Escalate issues to the relevant GSK CSD and Manufacturing Site Complaints Coordinator (in all countries).
Day to day management of AE, incident and pregnancy reports in GSK sponsored clinical studies within specific timeframes.
Notify the appropriate legal department and Head of the relevant CSD of any potential or actual legal action or liability with respect to human safety.
Responsible for governance of the Pharmacovigilance/Medical Information operations within designated clusters and coordination of central requests.
Serve as Internal GSK reference point of contact for Local Operating Companies (LOCs)/Rep Offices/Do Not Promote (DNP)/Direct to Government (DTG) and central teams.
We are looking for professionals with these required skills to achieve our goals:
PharmD (Pharmacists degree)
2 or more years of experience working in the pharmaceutical industry
Experience in Pharmacovigilance and Medical Information regulatory requirements, systems, and processes
Experience with medical governance across multiple geographies
If you have the following characteristics, it would be a plus:
Doctor of Medicine (MD)
Strong collaboration, planning, execution, and communication skills
Ability to influence across a highly-matrixed organization
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
US work authorization is required for this role. Sponsorship is not available for this position
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).
GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.