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Dublin, , Ireland
Affiliate Safety Representative
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on , , , , and .
Job Description
Lead the coordination and execution of all aspects of pharmacovigilance (PV) at the affiliate to ensure that all of AbbVie’s statutory and ethical responsibilities are met. Act as the Affiliate’s main contact point for pharmacovigilance matters with the National Regulatory Agency and AbbVie Pharmacovigilance and Patient Safety (PPS) function. Provides strategic leadership to manage and support the PV team in executing assigned responsibilities. This position reports into the Affiliate Medical Director. For all PV-related matters this position has additionally a dotted-line indirect reporting relationship to the EU QPPV.
Leadership and management
Build and maintain effective business relationships across the affiliate to support the implementation of patient safety standards.
Maintain an environment of continuous improvement to optimize the affiliate PV system and contribute to regional and global process improvement initiatives,
working with PPS subject matter experts.
Support recruitment, on-boarding, training, development through coach and mentoring, performance management, and succession planning of appropriately skilled PV staff
Oversight of Pharmacovigilance System:
Maintain oversight of affiliate PV compliance status, including the compliance status of outsourcing vendor, and actively monitor PV workload and resources
Escalate compliance issues and potential PV resource affiliate projects involving activities where there is a reasonable possibility for the identification and/or handling of safety information inclusive of Digital media and internet are assessed for the generation of safety information and the applicable PV requirements are applied in accordance with AbbVie procedures and local requirements.
Safety Data Exchange Agreements (SDEA) and other PV
Agreements:
Ensure the content of local SDEAs and other PV agreements conforms to AbbVie procedures and local requirements and maintains the inventory in the PPS PV Agreements Database.
Maintain and monitor compliance with local agreements.
Audits and Inspections:
Act as the key Affiliate contact for both internal PV audits and
Regulatory Agency PV inspections.
Ensure that any audit/inspection responses/corrective actions are completed according to the schedule.
Support local QA and R&D PV QA to conduct vendor audits and complete vendor corrective action plans.
Risk Management:
As a member of the Affiliate Risk Management Team (ARMT), review Risk Management Plans (RMPs) and implement risk minimization measures at the affiliate according to AbbVie procedures and local requirements.
Understand the RMPs and information on the benefit/risk profile of products applicable for the Affiliate.
Ensure the appropriate development and revision of Local RMPs and/or Country Specific Annexes, if applicable, liaising with ARMT & Benefit Risk Management (BRM) Team during development and revision of local documents.
Partner with ARMT & Benefit Risk Management (BRM) Team during development or revision of the Local Implementation Plan (LIP) & local additional risk minimization measures.
Safety Monitoring:
Maintain overview of medicinal product safety profiles and any emerging safety concerns for company products marketed within the relevant jurisdiction, and awareness of conditions or obligations adopted as part of the marketing authorizations, commitments relating to safety or the safe use of the products and of post-authorization safety studies requested by a regulatory agency.
Understand and monitor incoming local safety data and communicate changes or potential concerns to the PPS Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.
Ensure a full and prompt response to regulatory agency requests for provision of additional information necessary for the benefit-risk evaluation of a medicinal product.
After Hours Availability& Business Continuity:
Ensure that an after-hours process is in place for the reporting of AEs.
Ensure that a Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV.
Critical Success Factors:
Builds and maintains strong relationships with affiliate colleagues (e.g. Medical Affairs, Regulatory Affairs, Commercial) and PPS and tailors communication to
different stakeholders to enhance understanding of PV requirements and elevate the PV internal brand
Learns fast, grasps the “essence”, ability to manage complexity and changes to change course quickly where indicated to add value to the PV system
Acts consistently with AbbVie’s ethics, obligations and local laws –putting patient safety, partnerships and overall AbbVie’s interests before individual, immediate team and functional interests
Focused on compliance; identifies, manages and escalates issues in a timely manner
Strengthens the use of product safety knowledge and channels scientific safety evidence and benefit-risk information to area and affiliate stakeholders to
positively impact business strategies.
Qualifications
Medical, pharmacy or life-sciences degree (or equivalent).
Minimum of 2- 5 years’experience working in the pharmaceutical industry in a in a pharmacovigilance role is required and experience in management of direct reports preferred.
Excellent written and spoken communication and presentation skills.
Fluency in written and oral English is essential to facilitate communications with Pharmacovigilance and Patient Safety, Area/Regional Medical and other headquarters functions.
Fluency in written and oral local language a requirement in order to facilitate communications within the affiliate medical department, and with the
National Regulatory Agency.
High customer orientation
Strong commitment to compliance with the relevant
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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AbbVie
Slangs & AI meanings
It's something that said when someone is when you're being spiteful to some on. Although, It's said in different manners. It could be used as A condolence. ex. "Man, I just lost $20..." "Hahahaha, You salty as hell!!" or "Salty Balls" Although, It's said in different manners. It could be used as A condolence. ex. "Man my grandma just died." "Aw man, That's salty."
Salty is American slang for a tough and aggressive sailor. Salty is American slang for a seagoing ship.
Taffety is Dorset slang for choosy.
A safe harbour, including natural harbours, which provide safety from bad weather or attack.
Safety is Black−American slang for ones bed.
Softy is slang for a weak, feeble or over sentimental person.
A break in the workday when employees gather to ingest drugs; "There is going to be a safety meeting in 5 minutes."
to have a bad attitude towards someone or something. "Don't be all salty with me!"Â
To feel stupid. Used as "Man after my pants split and my underwear where showing I felt salty!".
1) Verb. To make someone angry. eg. "Back off, I'm getting hella salty"
It's something that said when someone is when you're being spiteful to some on. Although, It's said in different manners. It could be used as A condolence. ex. "Man, I just lost $20..." "Hahahaha, You salty as hell!!" or "Salty Balls" Although, It's said in different manners. It could be used as A condolence. ex. "Man my grandma just died." "Aw man, That's salty."
adj similar: We looked at ten flats that afternoon but they were all just a bit samey.
Salty water is slang for Gamma Hydroxy Butyrate.
Saffy eyes is slang for puffy, baggy sleepy eyes.
Not Applicable -or- Not Affiliated
Jump salty is American slang for to suddenly become angry.
Affiliate Safety Representative
It's something that said when someone is when you're being spiteful to some on. Although, It's said in different manners. It could be used as A condolence. ex. "Man, I just lost $20..." "Hahahaha, You salty as hell!!" or "Salty Balls" Although, It's said in different manners. It could be used as A condolence. ex. "Man my grandma just died." "Aw man, That's salty."
Salty is American slang for a tough and aggressive sailor. Salty is American slang for a seagoing ship.
Taffety is Dorset slang for choosy.
A safe harbour, including natural harbours, which provide safety from bad weather or attack.
Safety is Black−American slang for ones bed.
Softy is slang for a weak, feeble or over sentimental person.
A break in the workday when employees gather to ingest drugs; "There is going to be a safety meeting in 5 minutes."
to have a bad attitude towards someone or something. "Don't be all salty with me!"Â
To feel stupid. Used as "Man after my pants split and my underwear where showing I felt salty!".
1) Verb. To make someone angry. eg. "Back off, I'm getting hella salty"
It's something that said when someone is when you're being spiteful to some on. Although, It's said in different manners. It could be used as A condolence. ex. "Man, I just lost $20..." "Hahahaha, You salty as hell!!" or "Salty Balls" Although, It's said in different manners. It could be used as A condolence. ex. "Man my grandma just died." "Aw man, That's salty."
adj similar: We looked at ten flats that afternoon but they were all just a bit samey.
Salty water is slang for Gamma Hydroxy Butyrate.
Saffy eyes is slang for puffy, baggy sleepy eyes.
Not Applicable -or- Not Affiliated
Jump salty is American slang for to suddenly become angry.
Affiliate Safety Representative
In British politics, an affiliated trade union is one that is linked to the Labour Party. The party was created by the trade unions and socialist societies
Cruise Tears Into 'Mission: Impossible 7' Crew for Not Following COVID-19 Safety Protocols". Variety. Retrieved 20 January 2021. Fuge, Jon (23 December 2020)
United States House of Representatives elections in California were held on November 5, 2024, to elect the 52 U.S. representatives from the State of California
In rocketry, range safety or flight safety is ensured by monitoring the flight paths of missiles and launch vehicles, and enforcing strict guidelines
retiring state representative John Kooiker of Sioux County described his experience with the case as a member of the Iowa State House Public Safety Committee
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company/employer to enlist their name and its employees in the Fund. The SSF is an affiliate body of the Ministry of Labour, Employment and Social Security (MoLESS)
Nuclear safety is defined by the International Atomic Energy Agency (IAEA) as "The achievement of proper operating conditions, prevention of accidents
Sigma Gamma Rho has affiliate groups for women at different stages in life: Rhosebuds (elementary-age girls), the Rhoer Club Affiliates (teenage girls),