Head of Patient Safety

Description

Head of Patient Safety in the Nordics

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987, that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.

Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development.

Gilead is seeking an ambitious and experienced individual to fulfil the role of Affiliate Head of Patient Safety in the Nordics. This is a local role and is part of Gilead’s Patient Safety function. This is a broad, all-encompassing, and independent role that will undertake the management and conduct of all Pharmacovigilance (PV) activities, ensuring that local PV activities are conducted in compliance with applicable regulations and guidelines and internal company procedural documents.

The Affiliate Head of Patient Safety is full-time to ensure permanent and continuous availability. The Head of Patient Safety is a strategic partner with local and global teams ensuring the patient is at the forefront of decision making and that the highest patient safety standards are met. This role is a critical point of contact for the regulatory authority on all safety matters and for internal Gilead partners.

The ideal candidate will possess:

Scientific background along with a medico-scientific university degree e.g., Life Science or Pharmacy

Drug safety experience in the post-marketing environment

Comprehensive knowledge of global safety regulatory requirements and extensive knowledge of safety regulations and Good Pharmacovigilance Practices pertaining to the EU

Knowledge of local healthcare systems to enable input into local benefit / risk decisions and local Risk Management (RMPs)

Effective communicator (written and oral); concise, accurate and business appropriate

Proven ability to work cross-functionally

Demonstrates teamwork and initiative

Excellent attention to detail and be able to demonstrate and deliver high-quality work

Specifically, this role has the following responsibilities:

Maintain expert knowledge of local pharmacovigilance regulations through active participation in local industry forums, meetings, and seminars

Communicate impact of changes in local pharmacovigilance regulatory requirements to Patient Safety and specifically for submission of safety reports including PBRER/PSURs and creation of local Pharmacovigilance plans

Communication of safety related issues and information that may be of relevance to the identification of potential safety signals to Patient Safety / EU QPPV and local stakeholders

Act as the critical point of contact with the local Regulatory Authority for:

 Management of safety related queries

 Submission of PBRERs/PSURs, RMPs and Risk Minimisation Activities and safety signals

Pharmacovigilance inspections

Maintain expert local knowledge and oversight of:

The safety profile of locally marketed products and any emerging safety concerns

local studies and solicited programmes ongoing in the region and local post approval commitments

local licensing agreements (if applicable)

Provide input to ensure the appropriate development and revision of local benefit / risk documentation and RMPs and risk-minimization activities

Ensure a proactive and strategic approach to PV locally through partnership with the leadership team and business partners e.g., awareness and input into new product launches and oversight of local solicited programs, providing support and review of contracts to ensure alignment with global standards

Utilize and proactively participate in the Affiliate Head of Patient Safety Network and access available Patient Safety resources such as the Agreement Repository, Patient Safety Shared drive and the Patient Safety SharePoint to ensure access to current information, including global PV Agreements, PBRERs/PSURs, RMPs and the Pharmacovigilance System Master File

Attend and actively participate in quarterly Affiliate Head of Patient Safety network video or teleconferences and the annual Affiliate Head of Patient Safety face to face meeting where possible to share knowledge and best practices

Fulfil local legal PV responsible role

Management and Oversight of Local Quality Management System

Ensure availability of current organisation charts, job descriptions, Curriculum Vitae and training records for safety personnel at the national level

Train applicable staff and vendors in the Nordics on safety reporting procedures including the timely reporting of safety information, new hire training, sales and solicited programs training and ensuring all training is documented

Maintain knowledge of global Procedural Documents as they pertain to the national level and ensure that local Procedural Documents, including a local Business Continuity Plan / Crisis Management Plan are in place for specific local processes that are not covered by a global Procedural Document.

Ensure an after-hours process is in place locally for the receipt of safety requests and that the system is tested at least annually and that the test is documented

Review the monthly global compliance reports produced by Patient Safety and take necessary corrective actions locally as applicable

Ensure oversight of local Individual Case Safety Reports (ICSRs)

Ensure archiving of safety data in accordance with the Gilead’s retention policy and national requirements

Act as the key contact for Gilead internal PV audits

The ideal candidate will also be able to display engagement and commitment to the Gilead Core Values, which are:

Teamwork – Working together

Excellence – Being your best

Accountability – Taking personal responsibility

Integrity – Doing what’s right

Inclusion – Encouraging Diversity

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors:

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