Pharmacovigilance, Medical Governance & Operations Manager
- Taipei, Taiwan
Site Name: Taiwan - Taipei
Posted Date: Aug 6 2020
Medical Governance & Operations Manager:
- Represent and assist the Country Medical Director to ensure collaboration on planning and execution of all clinical & pharmacovigilance activities alongside internal stakeholders
- Member of the LOC medical leadership team, and ?risk management committee board.
- Assisting to collate information on behalf of the Medical Director, including periodic management monitoring, updates to risk registry/checklist and medical KPIs/matrixes.
- Designated Country Medical Information Champion with overall management of the operational and governance of Medical Information Process, including training of new Medical Affairs Managers or Field Medical Managers on how to use the MI system and SOP's, as well as liaising with Global MI teams to ensure compliance and conformity to the global MI Process.
- Designated Country Lead for Clinical Trials with overall management and oversight of all clinical trials occurring in Taiwan for GSK sponsored and investigator sponsored trials.
Named Safety Contact (NSC) for the Company, the person in this role has overall responsibility for the day-to-day management of pharmacovigilance for marketed products and products in clinical trials, including all pharmaceutical products, vaccines and consumer healthcare products for activities that your LOC is accountable for. This also includes ensuring compliance with all global pharmacovigilance requirements and all local regulations:
- Point of contact for local regulatory authority on PV related matters.
Training of all operating company staff & 3rd party service providers who require PV Training (including but not limited to Market Research Agencies, 3rd party sales forces, those providing services under Patient Support Programmes and Interactive Digital Media)
- Supports the General Manager, Country Medical Director, and Person Responsible for Pharmacovigilance in awareness and delivery of their pharmacovigilance responsibilities under corporate policies, standard operating procedures, and regulatory requirements
- Identify and implement appropriate safety processes and systems for effective business operations and corporate and regulatory compliance such as the labelling process requirements
- Assist regulatory unit and the LOC in terms of implementation of the GDS (if required)
- Monitor and improve the current level of activities in pharmacovigilance and ensure consistency and compliance with corporate policies, standard operating procedures, and regulatory requirements to protect patients, GSK's products, and GSK's reputation
- Coordinate GSK Taiwan planning and preparations for corporate and regulatory pharmacovigilance audits
- Manage the handling and reporting of all pharmacovigilance related matters used in clinical trials, compassionate use programs and for marketed products
- Support other departments in safety issues, i.e. participate in the preparation of risk minimisation programs and post-commitment issues.
- Active involvement in internal and external developments through close internal interactions and through participation in external safety meetings and assessment of external national safety information
- Generation and implementation of Pharmacovigilance Level 1 Self Inspection programme.
- Providing pharmacovigilance support for the legal teams when developing contracts/ agreements requiring PV Clauses or Safety Data Exchange Agreements.
- Mentoring and coaching of Associate NSC
- Performance tracking of the Named Safety Contact Back-up.
- Training of the project team about safety requirements of the study.
- INDSR reporting: It includes reporting of Initial occurrence of an SAE, its follow-up information to the Investigator, to the relevant regulatory authorities and to other participating sites within the timelines of local regulations and internal advice.
- To liaise with clinical team to ensure that clinical trials updates are communicated to the Named Safety Contact for proper dissemination of information to sites and regulatory authorities
Basic Qualifications: We are looking for professionals with these required skills to achieve our goals:
- PharmD (Pharmacists degree) or Doctor of Medicine (MD)
- At least 5 year's experience in medical function of pharmaceutical industry or related fields (ADR Reporting Centre, Pharmacist in hospitals)
- Experience in Pharmacovigilance and Medical Information regulatory requirements, systems, and processes
- Experience with medical governance across multiple geographies
- Strong collaboration, planning, execution, and communication skills
- Ability to influence across a highly-matrixed organization
- Technical/ Professional Proficiency
- Meticulous and strong attention to detail
- Experienced in safety reporting function
- Experienced in risk management is a plus
- Good command of both spoken & written English
- Strong analytical skills
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:
- 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
Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing.
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