Find Associate director Jobs in Santry, D

Associate Director, Pharmacovigilance Operations (Contract)
PTC Therapeutics International Limited —DUBLIN 2, County Dublin
- Full-time
- Management
- Microsoft Office
- Bachelor's degree
Quick apply
2d
Data & AI Consultant – Associate Director - ROI / Belfast
Grant Thornton —Dublin, County Dublin
- Full-time
- Azure
- SQL
- Business development
9d
Project Director – Cost Management
AECOM —Dublin, County Dublin
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- IT
PGIM | Director, Designated Person For Fund Risk
Prudential —Dublin, County Dublin
- Full-time
- Python
- Annual leave
Associate Director - Dispute Advisory (Financial Expert Witness & Litigation Support)
KPMG —Dublin, County Dublin
- Hybrid work
- Writing skills
- Business development
- Analysis skills
- Relocation assistance
- Annual leave
Business Development Executive, Large Enterprise
Gartner —Dublin, County Dublin
- Full-time
- Sales
- Business development
- Bachelor's degree
- Annual leave
Associate / Associate Director (Development Transport Planning)
SYSTRA —Dublin, County Dublin
- Hybrid work
- No degree
- Civil Engineering
- Communication skills
Senior – Global Statutory Audit
Grant Thornton —Dublin, County Dublin
- Full-time
- No degree
- In-person
- Communication skills
Senior Associate Director, Client Trade Operations - 12 months duration
MUFG Investor Services —Dublin, County Dublin
- No degree
- Leadership
- Annual leave
- Gym membership
Quick apply
7d
ERP Project Director
PM Group —Dublin, County Dublin
- Oracle
- Computer Science
- ERP systems
Senior Procurement Director, Sugar EMEA
Coca-Cola —Dublin, County Dublin
- Full-time
- Master's degree
- Analysis skills
- Bachelor's degree
2d
Senior Associate / Associate - Global Risks & Financial Lines (Complex Litigation) - Dublin
DWF —Dublin, County Dublin
- Full-time
- Hybrid work
- Communication skills
Associate Director – Corporate Audit
Grant Thornton —Dublin, County Dublin
- Full-time
- Communication skills
Associate Director - Mechanical
EDC Engineering Design Consultants LTD. —Dublin, County Dublin
- Overtime
- Hybrid work
- Master's degree
- Team management
- Leadership
- Annual leave
- Work from home
Quick apply
10d
Associate Director, Web Analytics
Novartis —Dublin, County Dublin
- €83,800.50–€155,629.50 a year
- Full-time
- Business
- Analytics
Company Secretary/Board Governance - Associate
BlackRock Investments —Dublin, County Dublin
- €75,000–€105,000 a year
- Organisational skills
- AI
- Communication skills
- Work from home
16h
Tax Manager
Russell Brennan Keane —Dublin, County Dublin
- Business development
- Communication skills
- Employee assistance program
Transportation Engineers/Planners
DBFL Consulting Engineers —Dublin, County Dublin
- Full-time
- Hybrid work
- Engineering
- Master's degree
- Analysis skills
- Annual leave
Senior Associate (Corporate Governance & Company Secretarial)
PwC —Dublin, County Dublin
- Full-time
- Recruiting
- Organisational skills
- Communication skills
Associate Director – Electrical Engineer
AECOM —Dublin, County Dublin
- Full-time
- Hybrid work
- Bachelor's degree
- Electrical Engineering
- Leadership
8d

I want to receive the latest job alerts for associate director in santry, d

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

associate director jobs near santry, d

Senior Auditor jobs in Dublin, County Dublin

Delivery Manager jobs in Dublin, County Dublin

Electrical Engineer jobs in Dublin, County Dublin

Secretary jobs in Dublin, County Dublin

Tax Manager jobs in Dublin, County Dublin

Head Of Project Management jobs in Dublin, County Dublin

Business Development Executive jobs in Dublin, County Dublin

Associate Director jobs in Dublin, County Dublin

Transport Planner jobs in Dublin, County Dublin

Data Consultant jobs in Dublin, County Dublin

Senior Finance Associate jobs in Dublin, County Dublin

Governance Officer jobs in Dublin, County Dublin

Associate Director jobs in Galway, County Galway

Business Transformation Director jobs in Dublin, County Dublin

Managing Director jobs in Louth, County Louth

Pharmaceutical Finance Director jobs in Dublin, County Dublin

Senior Parts Advisor jobs in Dublin, County Dublin

Senior Network Engineer jobs in Remote

Senior Digital Marketing Executive jobs in Dublin, County Dublin

Delivery Manager jobs in Cork, County Cork

Associate Director, Pharmacovigilance Operations (Contract)

PTC Therapeutics International Limited -
DUBLIN 2, County Dublin

Quick apply

Job details

Full-time
2 days ago

Qualifications

Biology
Management
Microsoft Office
Bachelor's degree
Data entry
Communication skills
Time management

Full job description

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life’s moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

Job Description Summary:

The Associate Director, Pharmacovigilance Operations oversees Pharmacovigilance Operations activities, both internally supported and outsourced, including the collection, processing, assessment, monitoring and follow-up of all types of safety information from various sources, including clinical trials and post-marketing, and any other PV Vendor deliverable
The incumbent ensures all relevant Pharmacovigilance guidelines / regulations are adhered to and works cross-functionally with internal departments and external resources on ICSR and safety database related matters. This includes providing strategic and operational oversight of PTC’s Pharmacovigilance (PV) vendor.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

Leads, oversees and actively contributes to the development, implementation and maintenance of a robust safety reporting system compliant with current applicable regulations. This includes closely managing the PV vendor and the case workflow, reviewing samples of cases to ensure ICSR quality and compliance with regulatory timeframes.
Supports training the PV vendor on new products and compliance requirements.
Supports PV set up and implementation of new studies / programs, including interventional Clinical Trials and Post-authorisation safety studies.
Reviews and contributes to PV vendor operational documentation, e.g. operational plans, program specific work-instructions.
Oversees safety database configuration, ensuring it meets applicable regulations and program needs.
Ensures the quality, completeness and timeliness of delivery of all outputs from the safety database supporting routine safety oversight activities, aggregate reports, ad-hoc Health Authority request etc.
Supports PTC’s PV strategic business continuity plan.
Authors ICSR-related processes and assists with the development, implementation and on-going enhancement of related SOPs.
Maintains and archives manual and electronic drug safety files pertaining to ICSR management.
Performs other tasks and assignments as needed and specified by management including line management

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Describe the following criteria, which are necessary to effectively perform the position:

Minimum level of education and years of relevant work experience.
BSN/RN, Bachelor’s degree in Biological Sciences, Pharmacy or PharmD degree preferred and a minimum of 7 years progressively responsible pharmacovigilance experience in a pharmaceutical, biotechnology or related environment, at least 3 of which were spent in a leadership role within pharmacovigilance operations.
Special knowledge or skills needed and/or licenses or certificates required.

Demonstrated expert knowledge of relevant Food and Drug Administration (FDA), European Union (EU) and International Conference on Harmonisation (ICH) guidelines, initiatives, and regulations governing pharmacovigilance.
Extensive, hands-on working knowledge of MedDRA terminology and the processing of AEs/SAEs in the pharmaceutical industry.
Demonstrated hands-on experience with Argus Safety database.
Demonstrated hands-on experience identifying, developing and implementing improvements to departmental processes that increase efficiency and maintain or improve quality (e.g., SAE reporting throughput rate).
Demonstrated ability to identify opportunities to improve the PV reporting process(es).
Ability to influence without direct authority.
Proficiency with Microsoft Office.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Special knowledge or skills and/or licenses or certificates preferred.

Understanding of safety database administration, configuration, data entry and extraction.
Expertise in the use of Electronic Document Management System (eDMS) software.
Expertise in WHODD with relevance to coding suspect drug and concomitant medications.

Travel requirements

0-10%

Physical requirements (only note if the job requires physical capacity beyond general office work)

Office / Remote based position

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

Click here to return to the careers page

Quick apply

Refine Your Search

associate director jobs in santry, d

Associate Director, Pharmacovigilance Operations (Contract)

Data & AI Consultant – Associate Director - ROI / Belfast

Project Director – Cost Management

PGIM | Director, Designated Person For Fund Risk

Associate Director - Dispute Advisory (Financial Expert Witness & Litigation Support)

Business Development Executive, Large Enterprise

Associate / Associate Director (Development Transport Planning)

Senior – Global Statutory Audit

Senior Associate Director, Client Trade Operations - 12 months duration

ERP Project Director

Senior Procurement Director, Sugar EMEA

Senior Associate / Associate - Global Risks & Financial Lines (Complex Litigation) - Dublin

Associate Director – Corporate Audit

Associate Director - Mechanical

Associate Director, Web Analytics

Company Secretary/Board Governance - Associate

Tax Manager

Transportation Engineers/Planners

Senior Associate (Corporate Governance & Company Secretarial)

Associate Director – Electrical Engineer

I want to receive the latest job alerts for associate director in santry, d

Related Searches

Explore jobs in more locations

Job Description Summary:

Job Description:

Jobseeker tools

Employer Tools

Browse

Stay Connected