Manager, Local Pharmacovigilance Job at Cencora (Mechelen)

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

New

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

New

Senior Patient Safety Specialist

Location

Philippines , Manila

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Expert knowledge of drug safety regulations and pharmacovigilance processes
Strong analytical and problem-solving abilities
Excellent communication and presentation skills
Superior organizational and time management capabilities
Proficiency with pharmacovigilance systems and databases
Proven experience in safety case management and regulatory reporting
Proficiency with safety databases and data analysis
Strong knowledge of ICH guidelines and regional requirements
Demonstrated mentoring abilities and process improvement skills
Experience in pharmaceutical or healthcare environments

Job Responsibility

Maintain expert-level knowledge of safety profiles, labeling, and global regulations
Lead development of project-specific procedures and workflows
Provide technical guidance to junior team members
Prepare for and participate in audits and inspections
Analyze metrics and drive continuous improvement
Collaborate with cross-functional teams on safety deliverables
Identify risks and recommend mitigation strategies
Ensure compliant documentation and archiving
Lead project management including safety procedure development and database setup
Coordinate ICSR processing workflows and perform case assessment (seriousness, causality, expectedness)

Local Safety Officer

As a Local Safety Officer (LSO) for Portugal, you will support pharmacovigilance...

Location

Portugal

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Medicine, Pharmacy, Nursing, or a science-related field (or equivalent experience)
Minimum 2 years’ experience in pharmacovigilance
Experience in local PV case management and regulatory communication
Familiarity with Portuguese regulatory environments
Fluent in Portuguese (written and verbal)
Excellent English proficiency
Strong organizational and interpersonal skills
Excellent time management and attention to detail
Proficient in MS Word and Excel

Job Responsibility

Act as back-up Local Safety Officer (LSO) and LPPV for PLG clients in Portugal, serving as a 24/7 contact for local regulatory authorities and ensuring service continuity
Maintain and update local pharmacovigilance documentation (PSMF, SOPs, SDEA, PVA, TA) and support local PV systems
Receive, process, translate, and submit safety cases (ICSRs) in accordance with Portuguese legislation
conduct periodic reconciliations of vigilance reports
Provide or support local medical information services
monitor local literature and regulatory websites for safety updates, and report findings to clients
Coordinate outsourced local safety activities, support local studies and risk minimization measures, and translate/submit DSUR, PSUR, and RMP documents as needed
Deliver pharmacovigilance training to stakeholders (sales reps, distributors, affiliates)
Liaise professionally with clients, affiliates, and third-party vendors, and participate in audits/inspections
Flex working hours to support Brazil mailbox coverage during absences

Fulltime

New

Regulatory Affairs Manager

This role is in support of Almus & Alvita, a Cencora business offering a trusted...

Location

United Kingdom , Woking

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Degree in life science of science
Experience working within European Regulatory Affairs team, supporting pharmaceutical products and or medical devices or cosmetics
Competent in managing European Procedures (MRP/DCP’s)
Good communicator, both orally and in written form
Good interpersonal skills. Proven ability to operate within a multifunctional team
Analytical, diligent and accurate
Excellent organisational skills and ability to prioritise
Can do attitude, with strong accountability and ownership
Comfortable with a fast pace and switching between competing priorities
Fluent English

Job Responsibility

Responsible for managing the regulatory tasks in launching multiple NPD (New product Development) projects as part of a multifunctional team, in accordance with the budget and 5 year plans
Support the European Brand Manager and Central Sourcing Team in assessing potential new Alvita products, the launch in new territories, the evaluation of claims and product attributes of products offered by alternative suppliers
Review and approve Product Specifications and Artwork Management Sheets (AMS), supporting the launch of new Alvita products and update of existing products. Work collaboratively with other colleagues responsible for originating artwork and provide final approval of artwork for allocated projects
Assess the regulatory requirements for products ensuring the product and its labelling are legally compliant
Responsible for becoming the subject matter expert on medical devices within the business and ensuring plans are in place to maintain compliance with the requirements of Medical Devices Regulation (EU) 2017/745 and the in Vitro Diagnostic Medical Device Regulation (EU) 2017/746, in the context of our obligations as an own brand
Ensure that Regulatory Intelligence data is maintained and updated according to the relevant processes. Demonstrate an innovative approach to obtaining market intelligence from suppliers and/or other sources, which can support the brand and local commercial teams in identifying new product opportunities and developing long-term NPD plans
Support the business on regulatory impacting changes, to ensure the necessary steps are taken to mitigate risk to the business
Manage the preparation and submission of the Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP) Marketing Authorisation Applications (MAAs), involving more than one market
Co-ordinate the management of variations with suppliers and local regulatory teams for European Procedures involving more than one market, ensuring all MAs and products in market meet necessary legal compliance
Manage the preparation and maintenance of Regulatory Compliance Files with the local affiliates and suppliers for European Procedures involving more than one market

Fulltime

Local Safety Specialist

The Local Safety Specialist acts on behalf of PLG clients in the Benelux region ...

Location

Belgium, Netherlands

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degree in Medicine, Pharmacy, Nursing, or a life‑science related field, or equivalent experience
5+ years of pharmacovigilance experience
Strong knowledge of Benelux and international PV regulations
Experience acting as a local PV contact in the Benelux region (preferred)
Hands‑on experience with local PV case management, including receipt, translation, submission, and follow‑up
Audit and inspection experience
Experience in literature and regulatory website monitoring (preferred)
Project management and client‑facing experience
French and Dutch: Native and/or fluent (written and verbal)
English: Excellent written and verbal fluency

Job Responsibility

Act as Local Safety Specialist and LPPV (as applicable) for PLG clients in the Benelux region
Serve as 24/7 local point of contact with regulatory authorities
Notify local authorities of appointments and ensure regulatory compliance
Maintain up-to-date knowledge of local Belgium, Netherlands, and Luxembourg PV regulations
Ensure continuity of local vigilance activities delegated to PLG
Communicate professionally with regulatory authorities and clients within agreed timelines
Create and/or maintain local Pharmacovigilance System Master File (PSMF) where required
Support and maintain the local PV system, including development of local SOPs and agreements
Review and update SDEA, PVA, and Technical Agreements (TA) as needed
Liaise with clients, affiliates, and third-party vendors

Fulltime

New

Senior Specialist Project Management Support

PharmaLex, part of Global Consulting Services (GCS) are seeking a Senior Special...

Location

Bulgaria , Sofia

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Professional degree in Sciences or Economics
Experienced user of the MS-office packages (excellent Excel knowledge), ERP-, project management- and database-systems
Basic understanding/knowledge in the field of pharmacovigilance
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 solutions
English business fluent & local language (as appropriate)

Job Responsibility

Program Management Support in the field of large volume outsourcing programs
Coordination, monitoring and preparation of project controlling and reporting
keeping an eye on the project’s overall budget
Informing the Customer Success Manager about potential discrepancies on budget
Support the tracking and reporting of set out targets (KPIs)
Initiation the control/ closing/ opening/ rebooking of times within work packages in PharmaLex Time tracking & Accounting System
Maintenance of program related projects in PharmaLex Time tracking & Accounting System from operative point of view
Supporting the onboarding / offboarding of resources (internal and external) as instructed by the Customer Success Manager
Compilation of regular check-point customer presentations
Keeping the overall reporting results transparent to the Customer Success Manager

Fulltime

Data Officers (Pharmacovigilance)

ProductLife Group is looking for Data Officers (Pharmacovigilance) to join our d...

Location

Philippines

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

Bachelor’s or Master’s degrees (according to the country and the experience) in Medicine, Pharmacy, nursing, or science related field, or equivalent experience
2+ years’ experience in pharmacovigilance working for service providers performing data entry and QC of cases
Previous experience working to deadlines
Client communications
Knowledge of UK and EU PV regulations
Pharmaceutical background – strong understanding of GVP, GCP, FDA and regulatory requirements related to drug safety
Deep knowledge of pharmacovigilance principles, adverse event reporting, causality assessment
Excellent organizational and interpersonal skills
Ability to work well within a team
Excellent time management skills

Job Responsibility

To perform local safety case receipt, processing and data entry, quality control (QC) tracking and ICSR follow up of all safety information received for PLG clients, in accordance with agreed timelines, as required
Management of the generic or client specific email boxes as appropriate
Registration, triage, assignment and coordination for the processing of vigilance cases
Follow-up requests with local reporters
Responding to queries from client and reporters
To carry out periodic reconciliations aimed at confirming the proper handling of all vigilance reports for PLG Clients
Support/Contribute to local pharmacovigilance (PV) activities performed by the Local safety/PV department as needed
To participate in audits / inspections and resulting action plan

Fulltime

Manager, Local Pharmacovigilance

Cencora

Location:
Belgium , Mechelen

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
February 20, 2026

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