Pharmacovigilance Manager Job at Theramex (Warsaw)

Pharmacovigilance Project Manager

The Pharmacovigilance Project Manager position with PrimeVigilance offers an opp...

Location

United Kingdom , Guildford

Salary:

Not provided

PrimeVigilance

Expiration Date

Until further notice

Requirements

PV Project Management experience from ideally a service provider / CRO
Life Science / Biomedical background – healthcare related degree (chemistry, biology, biotechnology, veterinary science)
Excellent client-facing skills including strong communication and presentation skills
Time management, organisation and multitasking skills with good attention to detail
Advanced English skills, both verbal and written, at least B2
Advanced knowledge of MS Office

Job Responsibility

Acting as the primary contact point for project-related matters for the client and internally
Maintaining good client relations and ensuring a consistently high quality of work
Preparing project scope and objectives based on the signed agreement between the client and PrimeVigilance
Project activity planning, including meeting deadlines and interim milestones
Reporting for the client and PrimeVigilance management e.g. preparation of Monthly reports, serving as basis for invoicing

Pharmacovigilance and regulatory affairs manager BeNeLux

Responsible for overseeing Regulatory affairs and Pharmacovigilance activities a...

Location

Netherlands , Utrecht

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 5-10 years of experience in regulatory affairs and pharmacovigilance within pharmaceutical company
Knowledge of local pharmaceutical legislation for Regulatory in the BeNeLux region
Knowledge of applicable laws and regulations to ensure full compliance
Knowledge of Regulatory affairs and Pharmacovigilance activities (act as primary contact for regulatory authorities and for external consultants in the regions, ensuring compliance of Product Information, API, approval of artworks for packaging materials and implementation of aRMM)
Proficiency in speaking, comprehending, reading and writing Dutch is required
Proficiency in speaking, comprehending, reading and writing English is required
Ability to think strategically & execute tactically

Job Responsibility

Act as local single point of contact for global functions in Regulatory Affairs and Pharmacovigilance for the BeNeLux
Act as the Local Safety Officer (LSO) for the Netherlands, Belgium and Luxembourg
Act as primary contact for regulatory authorities and for external consultants, ensuring compliance of Product Information, approval of artworks for packaging materials and implementation of aRMM
Responsible for creating and keep the local Regulatory affairs and Pharmacovigilance SOPs up to date
Responsible for training of BeNeLux team in local Regulatory affairs and Pharmacovigilance SOPs
Work closely together with Pharmacovigilance and regulatory affairs managers within the BNS cluster (BeNeLux Nordics and Switzerland) creating a network of knowledge and international cooperation and support
Collaborate with commercial, medical and market access to realize cross-functional objectives

What we offer

Competitive salary and benefits package
Opportunities for professional growth and development

Regulatory/pharmacovigilance manager

This professional performs precise tasks aimed at checking legislation and drug ...

Location

Salary:

Not provided

Polifarma SpA

Expiration Date

Until further notice

Requirements

Graduate in medicine and surgery or in pharmacy, chemistry and pharmaceutical technology, biology or chemistry
Knowledge of clinical trials and quality systems
Previous experience in the post
Knowledge of national and EU legislation in the field of chemical products
Ability to archive and register documents
Ability to use data archiving software
Ability to produce information on regulatory aspects in the chemical field
Ability to apply techniques for drafting informative reports
Ability to complete paperwork for manufacturing products or apply administrative procedures for issuing permits, disclaimers and authorisations.

Job Responsibility

Ensure that all information concerning the safety of products after they have obtained marketing authorisation are brought quickly to the attention of health personnel
Draft the Periodic Safety Updated Reports (PSURs) and forward reports of suspected serious adverse and unexpected reactions to the national pharmacovigilance system
Notify the Pharmacovigilance Office of the Ministry of Health of any initiative adopted by other countries for safety reasons
Disseminate information notices and safety updates to prescribers
Maintain the MA and new registrations, even extra-EU
Activities linked to pharmacovigilance (collection of reports, any insights, database entries, follow-up)
Archiving and registering documents
Produce information on regulatory aspects in the chemical field
Apply techniques for drafting informative reports
Complete the paperwork for manufacturing products or apply the administrative procedures for issuing permits, disclaimers and authorisations.

Gvp compliance lead

BioMarin is looking for an individual with experience working in Pharmacovigilan...

Location

United States

Salary:

176000.00 - 242000.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

10+ years of experience working within a regulated healthcare industry including a role in capacity of quality and compliance
Working knowledge of FDA, EMA, and global PV Regulations, and application of Good Pharmacovigilance Practices (GVP), ICH and GCP regulations
Experience working in Pharmacovigilance (PV) within Quality and Compliance
Experience executing or managing Health Authority Inspections
Experience executing or managing R&D Audits and GVP Audit Program
Experience with identifying optimal strategy for executing a GVP audit program working with internal auditors and external consultants
Experience navigating and understanding a quality management system
Core leadership competencies in strategic thinking, agility, prioritization, communication and decision making
Experience in managing staff and leading teams
Strong verbal, written and oral communication skills. Able to present to Senior Leadership.

Job Responsibility

Championing the implementation of Global Quality vision, policies, processes, and decisions
Collaborate with stakeholders to identify, communicate, and mitigate compliance risks
Continually enhance partnerships with key stakeholders and leaders across the business
Support and drive the implementation of quality and compliance projects and objectives
Stay updated on regulations and recommend proactive compliance changes when necessary
Develop and enhance GVP Compliance processes and best practices
Lead the execution of the GVP Compliance Global Audit Program
Act as a GVP compliance core team member on regulatory inspection teams and support mock readiness activities
Provide insights to continually optimize the GVP Compliance Audit Program
Contribute to Pharmacovigilance System Master File (PSMF) updates

What we offer

company-sponsored medical, dental, vision, and life insurance plans
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off

Fulltime

Manager, Local Pharmacovigilance

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years’ experience and profound knowledge in the field of pharmacovigilance
Expertise, experience and knowledge regarding relevant legislative and non legislative guidelines on pharmacovigilance
Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads)
Ability to train and support junior/new colleagues in daily activities
ability to lead small project with clearly defined scope
Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level
Good communication skills (written and verbally)
capability to communicate issues and propose appropriate solutions to decision makers
Good presentation skills

Job Responsibility

Set up and manage the local pharmacovigilance system
Local Literature Search
Local ICSR Management
PV Intelligence Screening
Local PSMF Maintenance
Setting up local Organized Data Collection
Local PVA Management
Local adaptation and submission of PSUR / RMP
Local signal detection
Implementation of additional Risk Minimization Measures

Fulltime

New

Manager, Local Pharmacovigilance

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen

Salary:

Not provided

Cunesoft

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years’ experience and profound knowledge in the field of pharmacovigilance
Expertise, experience and knowledge regarding relevant legislative and non legislative guidelines on pharmacovigilance
Leadership: Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads)
Task and project management skills: Ability to train and support junior/new colleagues in daily activities
ability to lead small project with clearly defined scope
(Customer) Relationship skills: Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level
Communication & presentation skills: Good communication skills (written and verbally)
capability to communicate issues and propose appropriate solutions to decision makers
Good presentation skills

Job Responsibility

Set up and manage the local pharmacovigilance system
Local Literature Search
Local ICSR Management
PV Intelligence Screening
Local PSMF Maintenance
Setting up local Organized Data Collection
Local PVA Management
Local adaptation and submission of PSUR / RMP
Local signal detection
Implementation of additional Risk Minimization Measures

Fulltime

Manager, Local Pharmacovigilance

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years’ experience and profound knowledge in the field of pharmacovigilance
Expertise, experience and knowledge regarding relevant legislative and non legislative guidelines on pharmacovigilance
Leadership: Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads)
Task and project management skills: Ability to train and support junior/new colleagues in daily activities
ability to lead small project with clearly defined scope
(Customer) Relationship skills: Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level
Communication & presentation skills: Good communication skills (written and verbally)
capability to communicate issues and propose appropriate solutions to decision makers
Good presentation skills

Job Responsibility

Set up and manage the local pharmacovigilance system
Local Literature Search
Local ICSR Management
PV Intelligence Screening
Local PSMF Maintenance
Setting up local Organized Data Collection
Local PVA Management
Local adaptation and submission of PSUR / RMP
Local signal detection
Implementation of additional Risk Minimization Measures

Fulltime

Senior Pharmacovigilance Associate

We are currently seeking a Senior Pharmacovigilance Associate to join our divers...

Location

Brazil , Sao Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, pharmacy, nursing, or a related field
High level of English proficiency
Based on Brazil - 100% remote position
Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards
Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection
Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations
Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams
Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite
Ability to work independently and manage multiple priorities in a fast-paced environment
Commitment to maintaining confidentiality and handling sensitive patient information with discretion

Job Responsibility

Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies
Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation
Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations
Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities
Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards
Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices
Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements
Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Pharmacovigilance Manager

Theramex

Location:
Poland , Warsaw

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
March 19, 2026

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