USA - Maryland - Rockville, USA - North Carolina - Research Triangle Park, USA - Pennsylvania - Upper Providence, UK - London - BrentfordPosted Date:
May 28 2020
This role is responsible for co-ordination, end to end evaluation, negotiation, and delivery of Safety Data Exchange Agreements (SDEAs) with Licensing Partners to ensure ViiV and/or GSK can meet its drug safety and vigilance obligations and ensure Patient Safety.
This role owns GSK Standard Operating Processes (SOPs) for SDEAs worldwide. This role is responsible for leading internal projects relevant to SDEAs, change management and making significant contributions to enable or improve compliance with global regulatory requirements for drug safety and vigilance.
The SDA will be required to:
- Manage end to end ViiV and/or GSK’s SDEA activities with business partners. These activities include without limitation:
- Acts as the primary Third-Party collaboration contact on all matters relating to SDEAs for internal and external stakeholders
- Performs due diligence of Third Parties’ vigilance systems prior to SDEA negotiation
- Initiates, negotiates and revises SDEAs as required
- Ensures compliance with worldwide PV, materiovigilance and cosmetovigilance regulations, guidelines and industry practice
- Applies standardised contract guidelines in line with company polices and legal and regulatory constraints
- Conducts routine reviews of SDEAs to ensure adherence with global requirements, GSK/ViiV business practices and the terms/status of the commercial agreement
- Trains internal and external stakeholders, as required, to ensure understanding of the terms of the SDEAs
- Works closely with relevant function across company including business development, legal departments, Quality, Medical Affairs to review and approve PV term in commercial agreements where needed
- Coordinates divestment activities, such as:
- Reverse due diligence and safety data preparation in collaboration with stakeholders from other safety departments
- implementation of separation activities related to safety data, e.g. safety database transfer to licensing partners
- Oversees compliance monitoring of SDEAs
- Supports Local Operating Companies (LOC) on local SDEAs
- Oversees the maintenance of the Pharmacovigilance Agreements (PVA) database, SDE website and other storage locations
- Runs standard listings from relevant safety and PVA databases, as required
- Acts as a contact point for audits, partner assessments and inspections
- Implements problem solving strategies across SDEA teams, such as root cause analysis and CAPA development
- Prepares, coordinates and delivers SDEA process training to relevant staff across company including LOCs, external PV vendors, legal departments and Business Development
- Develops and maintains process documents defining the responsibilities of GSK staff for due diligence of vigilance systems and negotiation and implementation of SDEAs
- Develops and maintains Global SDEA templates
- Keep up to date on regulatory/legislation changes and implement changes in SDEAs and SDEA processes/template when applicable
- Responds to queries on strategy/policy related decisions associated with SOPs/guidance documents
- Identifies risks to SDEA processes/groups and implements mitigation strategies
- Maintains knowledge and compliance of GSK’s processes and systems
- Manages multiple complex projects relevant to SDEAs
- Manages staff and oversee direct reports’ work if necessary
We are looking for professionals with these required skills to achieve our goals:
- Bachelor’s Degree in life sciences or equivalent
- Minimum 5 years of experience in Pharmacovigilance or equivalent
- Relevant experience in the pharmaceutical industry demonstrating a sound knowledge of pharmacovigilance regulations and safety data exchange agreements
- Extensive experience interacting with third parties (e.g., business partners)
- Experience working with teams and individuals in other parts of the business in a collaborative manner to develop business solutions and create value
- Proven project management skills and change management experience
- Experience of internal and/or external audits and inspections
If you have the following characteristics, it would be a plus:
- Knowledge of various types of licensing partnerships and relevant key operational interfaces
- Comprehensive operational understanding of pharmaceutical development and approval processes in major countries, including world-wide pharmacovigilance requirements regulatory
- Advanced problem-solving capacities
- Proven ability to influence and negotiate with key internal and external stakeholders
- Ability to interact effectively and productively with senior, VP level staff
- Ability to deliver key process improvement initiatives
- Ability to work independently and take decisions with minimal supervision
- Management of cross functional global initiatives
- Attention to detail with necessary level of pragmatism where appropriate
- Project management skills in a global matrix environment
- Excellent knowledge or understanding of the contracting area
- Knowledge of data collection and manipulation – proficiency in MS Excel for data analysis preferred
- Ability to act as a training resource for selected activities
- Excellent command of written and spoken English
- Demonstrated strong teamwork/collaboration skills
- Motivates, supports and develops talent within the team
- Leads initiatives locally and globally
- Independently plans and organizes own work and effectively manages multiple priorities and responsibilities
- Demonstrates personal accountability for taking actions that drive the business
- Displays sound judgment in knowing when to escalate issues. Makes sound decisions in absence of manager
- Builds and maintains relationships with peers and superiors
- Recognizes impact of work on other functional areas
- Embraces tough challenges with confidence, enthusiasm and optimism
- Is creative and embracing innovation.
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:
- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk.
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
As a company driven by our values of Patient focus, Transparency, Respect and Integrity, we know inclusion and diversity are essential for us to be able to succeed. We want all our colleagues to thrive at GSK bringing their unique experiences, ensuring they feel good and to keep growing their careers. As a candidate for a role, we want you to feel the same way.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race/ethnicity, colour, national origin, religion, gender, 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*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Please don’t hesitate to contact us if you’d like to discuss any adjustments to our process which might help you demonstrate your strengths and capabilities. You can either call us on 0808 234 4391, or send an email email@example.com
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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