Senior Director Pharmacovigilance
- Warren, NJ
Site Name: Warren NJ
Posted Date: Mar 2 2020
An exciting opportunity has arisen for an experienced scientist or physician to lead a team of staff in GSK Consumer Healthcare's pharmacovigilance (PV) team. This global team is responsible for supporting the diverse range of products (over-the-counter-medicines, cosmetics, medical devices, and nutritionals) within GSK Consumer Healthcare (CH) as well supporting PV at the market level. The CH PV team works closely with the GSK Pharma and vaccines safety group who provide platform services to Consumer Healthcare.
The successful candidate will report to the Head, Consumer Healthcare Safety, will manage a team of 12 people as well as matrix-managing product activities for GSK's Wellness category across the global team. The majority of the team are located in GSK CH's site in Warren, New Jersey and are responsible for safety evaluation and risk management activities for GSK's CH portfolio. Other team members serve as safety points of contact for the Americas ensuring PV is conducted at the market level in a compliant manner and that commercial teams understand their obligations for collecting and reporting human safety information.
Your responsibilities and accountabilities, include, but are not limited to:
- Ensuring team of scientists and physicians manages safety of allocated products according to appropriate regulations and agreed processes.
- Ensuring timely production of key deliverables for team:
- Support to innovation within GSK CH and to switches from prescription to over-the-counter status
- Signal detection & evaluation
- Regulatory enquiries
- Product quality issues
- Periodic reports & renewals
- Label creation & maintenance
- Benefit risk assessment for due diligence activities
- Safety Data Exchange Agreement (SDEA) input
- Risk management activities as appropriate to allocated products and as issues arise
- Documentation to safety governance boards when issues arises
- Balancing resource requirements across the portfolio and promoting a pragmatic, flexible, focused approach to workload.
- Ensuring that the team has business objectives set, development plans in place and completes all training, as required.
- Leading and implementing process improvement projects.
- Delegated accountability for ensuring GSK Pharma delivers market-level safety services for CH according to a Shared Services Agreement and that commercial parts of the company understand their obligations for collecting and reporting human safety information.
Role Requirements As the successful candidate, you will be a credible leader with evidence of your ability to influence across a wide range of different functions. You will be expected to demonstrate the following behaviors:
- Leadership - ability to build & motivate team, mentor, coach, and develop individuals
- Change management
- Strategic thinking
- Innovative thinking
- Relationship building with key stakeholders
- Pragmatic approach
- Flexibility & agility
- Looking for ways to make processes more efficient
- Working to targets/achieving metrics
Basic Qualifications: The successful candidate will have 10-15 years of experience in drug safety or other relevant field, such as clinical development, regulatory or medical affairs, a working knowledge of key pharmacovigilance regulations and methodologies and experience of people management.
- Physician, pharmacist or biomedical degree (or equivalent), or above.
If you have the following characteristics, it would be a plus:
- Broad experience of PV at central and/or market level including post-marketing safety.
- Experience of different products types, medicines (Rx and non-Rx, cosmetics, medical devices, foods).
- Experience of process redesign
- Experience of decision making on product issues
Our values and expectationsare 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.
*This is a job description to aide in the job posting, but does not include all job evaluation details.
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