Regional Director, Pharmacovigilance Operations US
Site Name: USA - Pennsylvania - Philadelphia Posted Date: Jul 7 2021 To join Barbara's Development/Global Medical/Global Safety & Pharmacovigilance (PV) Ops team. Job purpose: The Regional Director of PV Operations ensures GSKs regional pharmacovigilance networks enable GSK to comply with global legislation protect patient safety and ensure excellence in safety. As Regional Director PV Ops US, your role is critical for Safety to evolve to a top quartile organization and spans across all business units, ViiV, Vaccines, Pharmaceuticals and Consumer Healthcare. You liaise with local, regional and global parties including Regional Medical Directors (RMDs), country General Managers (GMs), Country Medical Directors (CMDs), Named Safety Contracts (NSCs), and other Global Safety and LOC stakeholders in all countries based in the assigned region. You are responsible for providing guidance, advice to ensure compliance at the regional and country level and ensuring appropriate communication channels between GSK local operating companies and Global Safety Organization. You are responsible for driving accountabilities at the LOC level (local entities) and influencing local and regional Risk Boards to ensure safety risks are appropriately escalated and mitigated. Key Responsibilities: In this role you, Are responsible for providing guidance, advice, direction to ensure compliance at the regional/country level adopting a ‘one safety' approach. Interact with Regional and Country Medial Directors(CMDs), General Managers(GMs), and Commercial as needed, and on a periodic basis, to ensure strong PV connectivity, proactively identifying new programs, initiatives, strategies or risk which may impact the PV system. Interact with local Named Safety Contacts to ensure PV compliance in the regions/countries. Partner with senior local/regional and global roles outside of the PV organisation and membership at Regional Lead team forums and governance boards to develop strategies to reduce risk to the PV system. Escalate non-compliance in the region to Local Risk Board, the Head of Pharmacovigilance (PV) Operations), EEA QPPV and Head of Safety as appropriate Accountable for implementation of new regulations in their region by liaising with central/regional teams and third parties Attend Regional Medical Director Area Meetings, as needed Attend regional risk boards, partnering with NCS and CMDs to manage PV risks. Point of contact for LOC audit and inspections. Lead Network meetings (Monthly meetings replacing former NSC Networks) Embed/ Maintain Country Operations Manual template and LOC specific COMs with the NSCs Establish training curricula for LOC staff, NSC, CMD, and GM Generate the monthly metrics reports with the LOCs (feed in the Global information) Why you? Basic Qualifications: We are looking for professionals with the following required skills to achieve our goals (must-have): Bachelor's Degree and minimum of 10 years related experience in a biotechnology, pharmaceutical company, including line management of large operational delivery team's governance, and process redesign in regulated environment Pharmaceutical industry experience and knowledge of global and local PV process Sound knowledge of clinical trial methodology and pharmacovigilance regulations (clinical and post marketing) Leadership and managerial experience required Sound knowledge of regulatory guidelines and legislations, FDA, Health Canada, ICH, GCP EMA and other RoW countries Experience in Inspection/Audit Management and CAPA Management. Preferred Qualifications: The following characteristics are assets (nice-to-have): Skilled at working effectively with cross functional teams in a matrix organization Proven written and verbal communication skills Proven experience at influencing and interacting with all levels of management and departments within GSK and its business partners Experience with local or regional Risk Boards Demonstrated quickly understand the objective, evaluate risks, provide advice in an agile manner. Why GSK? 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, rigor and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritization, execution, delivering performance. Setting strategic direction and leading on-going organizational transformation. Building a resilient organization. Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit. Managing P&L and capital allocation. *LI-GSK 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.