We're got an amazing opportunity to join GSK as a Associate Director, Pharmacovigilance Agreements & Safety Clauses. The key purpose of this role is to ensure the safety of all GSK Clinical Trial participants, patients, and consumers administered or using GSK products, by supporting the successful collection, processing and reporting of safety data of GSK products globally.
This role ensures that pharmacovigilance (PV) operational activities align with GSK standards for processing human safety information (HSI) and that regulatory requirements, including timelines are achieved. This is done by driving the implementation of robust processes and training for successful performance of PV activities, including PV vendor oversight mechanisms.
The job holder provides relevant oversight to the PV Operations (PV Ops) Directors and drives the understanding of PV requirements across all business units.
As a , we empower you to be yourself, share ideas and work collaboratively.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Why You?Basic Qualifications:
- Support oversight of Pharmacovigilance Agreements and Safety Clauses (PVASC)
- Provide Management of activities performed by PVASC Managers, PVASC Authors and PVASC Compliance Leads
- Develop and maintain PVASC departmental procedures
- Oversee compliance activities related to PVASC and applicable company policies, procedures, and regulations to provide guidance for the PVASC authoring and compliance team as appropriate
- Support PVASC Oversight Lead with safety processes related to PVASC where applicable
- Supports the PVASC Director on long-range planning for departmental processes and resourcing requirements
- Participate in the development of processes and strategies designed to assist in meeting cross-departmental and company goals
We are looking for professionals with these required skills to achieve our goals:
- Bachelors Degree in life sciences or medically-related field
- 7 to 10 years' work experience within Pharmacovigilance (PV) industry
- Expert knowledge of Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP), clinical safety documentation, reporting of adverse events from clinical trials, local regulatory requirements, and pharmacovigilance methodology; general understanding of worldwide regulatory requirements
- Experience applying working knowledge of principles of data collection, manipulation and retrieval and experience summarizing data
- Expertise understanding medical and drug terminology
- Experience developing and delivering high-quality training and coaching others
- Experience identifying when escalation mechanisms are necessary and making suggestions/recommendations for a solution, based on a combination of facts, experience and PV knowledge
- Expert in the implementation of effective change management across a complex matrix environment
If you have the following characteristics, it would be a plus:
- Safety database knowledge (Argus), Regulatory database knowledge (OPAL)
- Knowledge of product lifecycle development
- Project management experience
- Ability to map processes and author written standards
- Knowledge and experience with pharmacovigilance systems
- In-depth knowledge of safety databases strongly preferred
- Strong communication skills
- Proven experience of prioritization and time management
- Solution-driven and proactive way of working
- Experience in line management
- Experience navigating difficult scenarios for conflict resolution
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, rigors 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
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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.
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