Global Safety Manager at Amigen

Athens, Attica, Greece -

Full Time

Start Date

Immediate

Expiry Date

21 Jul, 26

Salary

0.0

Posted On

22 Apr, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Pharmacovigilance, Regulatory compliance, Safety management, People management, Risk management, Crisis management, Data privacy, Medical terminology, Safety reporting, Quality assurance, Budget management, Stakeholder management, Inspection readiness, Database management, Training and development, Strategic planning

Industry

Biotechnology Research

Description

Career Category Safety Job Description HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach millions of patients worldwide. It’s time for a career you can be proud of. Join us. Role: Global Safety Manager Greece (Country Safety Lead) Organization: Global Patient Safety Team: International Safety Purpose: The purpose of this role is to act as the recognized safety responsible person in Greece and Cyprus, managing safety related activities within the local affiliate in line with Global Patient Safety (GPS) policies and procedures, local regulations and practices, and to link with functions in the local affiliate to meet business needs. WHAT YOU WILL DO: As part of Global Patient Safety, to be responsible for representing the local safety function on behalf of their country(ries) in interactions with regulatory agencies, GPS management, other functions locally and external health care professionals, to achieve Safety objectives. To manage the relevant affiliate Safety team to ensure compliant and efficient performance of safety activities locally, based on sound knowledge of local legislative requirements and practice, GPS policies and procedures, with an understanding of the business needs of the local affiliate. To participate in exchange of safety information throughout the Amgen Global organization to support informed understanding of product safety issues. Key Activities Broader Management and Co-ordination Activities: - Manages LSO and budget resources - Works with Regional Safety Leads on process improvement initiatives or implementation of legislative changes - Guides training and development activities for Greece & Cyprus - Participates in global/ regional /country safety meetings to share best practice - Provides input into cross functional programs, to reflect local requirements - Performs other duties related to the position as necessary as defined in Standard Operating Procedures or as requested by his/her supervisor Strategic Planning Activities: - Provides affiliate input to GPS senior management planning of regional safety organization development, capacity management, resourcing and talent management initiatives Activities as Local Safety Responsible Person (For Greece & Cyprus): - Is nominated to country regulatory authority as local safety responsible person - Acts as safety subject matter expert within the affiliate - Maintains own current knowledge of and compliance with local safety regulations for country or countries under responsibility - Communicates requirements and updates to Safety BPOs and line manager, and ensures local affiliates safety requirements are up to date in GPS SOPs and manuals - Ensures that local safety procedures are documented in line with Amgen /GPS policies and procedures - Collaborates locally with all relevant stakeholders to ensure 24 hour contact ability of the safety function for urgent issues is available - Works with local teams to establish, review and revise Pharmacovigilance and/or contract agreements with partners, contractors/vendors and distributors, as applicable - Ensures that training on adverse reporting obligations is available for local customer-facing staff and others required by national practice or Company policy, also for relevant contractors, agents or business partners or distributors - Participates in local Crisis Management teams; provides ongoing safety advice - Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness - Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility Management of Core Safety Affiliate Responsibilities: - Timely & accurate capture, routing, translation, and follow up of all adverse events reported to the local country(ies), , for inclusion in the Global Safety Database - Arranges safety review of local medical literature - Oversees submission of all reportable adverse drug reaction reports & the distribution of periodic safety reports, as required by local regulations and Amgen procedures. - Assists intake of product complaints in countries where local safety department is designated to support product quality department with this activity. - Collaborates in the planning and dissemination of urgent safety communications, Dear Healthcare Professional Communications (DHPCs) & Dear Investigator Letters (DILs) required by Amgen decisions or Regulatory Agency demands, according to local requirements. - Assists in tailoring of core risk management plans or periodic reports to local regulatory requirements, for specific countries not covered by regional versions. - Supports the local implementation of risk minimization activities associated with approved risk management plans - Facilitates exchange of adverse event information with functional service providers or business partners, or distributors, in line with specific agreements or procedures - Supports intake of product complaints if assigned in absence of local QA specialist Compliance Management: - Reviews metrics generated from Global Safety database to monitor local operating performance and reporting compliance within the affiliate Safety function, for AE case and periodic safety reports. - Takes responsibility for seeking resolution of local issues that occur, through CAPAs and related activities. - Ensures local quality assurance measures to support data quality and maintain inspection readiness of local safety function. - Provides local Safety expertise to local stakeholders for review of plans / vendor contracts of local market research studies and patient support programmes to ensure safety contract language, training, monitoring and data collection are appropriately addressed. - May provide local safety expertise for review of protocols of local interventional, non-interventional studies (NIS) and independently sponsored studies to ensure safety monitoring and data collection are appropriately addressed, liaising with Medical or SOPS teams as relevant. Additional local responsibilities: - Back-up for safety personnel of other affiliates as assigned - Local deputy QPPV for Greece per the country regulatory requirements WHAT WE EXPECT FROM YOU Knowledge and Skills Excellent working knowledge of Amgen's policies, procedures and systems Deep understanding of legislation which applies to safety practices locally Computer literacy with thorough knowledge of database use Thorough knowledge of local data privacy requirements Understanding of relevant medical & safety terminology Excellent organizational and people management skills Understanding of team dynamics Education & Experience (Basic) Master’s degree OR Bachelor’s degree and 2 years of directly related experience OR Associate’s degree and 6 years of directly related experience OR High school diploma / GED and 8 years of directly related experience Education & Experience (Preferred) •Professional qualification as a health care professional (doctor, pharmacist, nurse, vet) or doctoral degree •Experience in pharmacovigilance, biotech/pharma industry, clinically based or regulatory agency role WHAT YOU CAN EXPECT FROM US - Opportunities to grow within a global, science-driven organization - A diverse and inclusive environment where ideas are valued - A competitive Total Rewards package supporting well-being, career growth, and work-life balance APPLY NOW FOR A CAREER THAT DEFIES IMAGINATION Equal Opportunity Statement: Amgen is an Equal Opportunity employer and will consider you without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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Responsibilities

The Global Safety Manager acts as the recognized safety responsible person for Greece and Cyprus, managing safety activities in compliance with global policies and local regulations. They represent the local safety function in interactions with regulatory agencies and oversee the affiliate safety team to ensure efficient performance and inspection readiness.