Manager, Local Pharmacovigilance Job at AmerisourceBergen (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

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

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

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

SPC Global Medical Director - Ophthalmology

Join the team transforming care for people with immune challenges, rare diseases...

Location

United States , Cambridge, MA / Morristown, NJ

Salary:

178500.00 - 297500.00 USD / Year

Sanofi

Expiration Date

April 01, 2026

Requirements

Advanced degree (MD, PhD, PharmD) required
board certification (or eligible) in ophthalmology highly preferred
Minimum of 3 years of retinal disease expertise
at least 3 years of pharmaceutical/biotechnology industry experience preferred
Demonstrated experience in medical affairs or clinical development roles, including early pipeline management, KOL engagement, and scientific communication
Proven track record at country or global level
US market experience strongly preferred
Broad understanding of the drug development process, regulatory requirements, risk management, health authority interactions, and market access considerations
Expertise in retinal clinical science, therapeutic landscape, and evidence generation methodologies, including clinical trials and real-word evidence
Significant experience working with Research, Clinical Development, Commercial, Health Economic Value & Access teams

Job Responsibility

Serve as the medical representative, providing strategic input and ensuring alignment of ophthalmology medical tactics with overall brand objectives
Participate in cross-functional workstreams to design and implement global medical programs supporting the ophthalmology portfolio
Contribute to the Global Medical Affairs Plan for ophthalmology assets
Collaborate with Scientific Communications to develop high-quality materials for external medical engagement and deliver global medical training programs
Lead and execute global medical activities within the Medical Affairs Plan, including advisory boards, expert meetings, and symposia
Drive evidence generation initiatives (e.g., Investigator-Initiated Studies, Real-World Evidence projects) in line with the Integrated Evidence Generation Plan (IEGP)
Lead strategically assigned projects to advance scientific understanding and clinical application of ophthalmology therapies
Build and maintain strong KOL relationships globally
Ensure cross-functional collaboration with Commercial, Regulatory, Pharmacovigilance, and Market Access teams
review promotional and non-promotional materials in Veeva/PromoMats

What we offer

high-quality healthcare
prevention and wellness programs
at least 14 weeks’ gender-neutral parental leave
opportunities for career growth and development
promotion or lateral move opportunities, at home or internationally

Fulltime

Senior Technology Quality Auditor

Technology Auditors possess significant authority and decision-making power with...

Location

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety / pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management
Minimum of 2 years' experience in quality assurance, auditing, including sound experience of applicable GxP technology auditing
Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national and local regulations and laws related to clinical trials and other clinical research
Educated to degree level (technology, biological science, pharmacy or other health related discipline preferred) or equivalent qualification or clinical research experience
Master’s degree in a science, technology or industry related discipline, preferred.

Job Responsibility

Independently lead, plan, schedule, perform, and report a range of technology audits across all phases of Clinical Research which may include but are not limited to project related audits, system and process audits, supplier qualification and re-qualification audits in order to evaluate the quality system against the appropriate regulatory requirements, relevant procedures and applicable guidelines
Perform and deliver high quality audits / audit reports within specified timelines / budgets, independently or with limited oversight
Ability to review and, if necessary, identify improvements that enhance the quality and clarity of audit reports
Travel internationally for audits, as required
Collect and review responses to audit findings and follow-up / escalate inadequate or delayed responses as necessary to ensure timelines are met and responses of satisfactory quality are obtained and formally recorded
Act as point of consultancy for Operations and Quality with regards to the implementation of adequate CAPAs with effective and timely escalation of relevant Quality Events where required
Coordinate internal global process / system audits across regions and develop all necessary tools such as report templates, checklists and standard emails
Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time
Review audit reports, responses and other program deliverable to ensure consistent high quality
Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information for audits and other activities

Head of Regulatory Affairs

The Head of Regulatory Affairs is responsible for providing strategic leadership...

Location

India , Chennai

Salary:

Not provided

Randstad

Expiration Date

February 15, 2026

Requirements

Advanced degree (PharmD, PhD, MD, or MSc) in Life Sciences, Pharmacy, or a related field
Minimum of 10-15 years of experience in Regulatory Affairs
At least 5 years in a leadership role within a CRO or biopharmaceutical organization
Proven experience in global regulatory submissions and interactions with major health authorities (FDA, EMA, MHRA, CDSCO, etc.)
In-depth understanding of clinical development, GCP, and ICH guidelines
Strong track record in managing teams and leading complex regulatory projects across multiple therapeutic areas
Exceptional leadership, communication, and negotiation skills
Ability to translate complex regulatory requirements into practical strategies
Strong client relationship management and presentation abilities
High attention to detail with strong organizational and problem-solving skills

Job Responsibility

Develop and implement the CROs regulatory strategy aligned with corporate goals and client needs
Serve as the primary regulatory expert and advisor to senior management and project teams
Lead and mentor the Regulatory Affairs team
Build and maintain relationships with global regulatory agencies and industry associations
Oversee preparation, review, and submission of regulatory documents including INDs, NDAs, BLAs, ANDAs, IMPDs, CTAs, and other filings
Ensure regulatory compliance in all clinical trials
Develop and maintain global regulatory intelligence
Support clients with regulatory strategy, gap analysis, and submission planning
Establish and oversee systems for document management, tracking, and reporting of regulatory submissions
Partner with Business Development and Project Management teams to provide regulatory input during proposal development and client meetings

Fulltime

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Key Account Manager aHUS

Proclinical is seeking a Key Account Manager to join a dynamic team focused on r...

Location

Germany , München

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Background in biotechnology or pharmaceutical sales, preferably in the orphan market
Master's degree in biology, Chemistry, or a related field with a strong sales mindset
Ability to work independently and collaboratively in a team-oriented environment
Experience in managing scientific events and projects
Strong relationship-building skills with healthcare providers in both community and academic settings
Effective presentation and communication skills with the ability to address customer needs and concerns
Flexibility to work across different indications and target groups as required
Proficiency in Microsoft Office tools (Outlook, PowerPoint, Word, Excel) and reporting systems
Knowledge of pharmaceutical regulations in the country
Willingness to travel regularly within the territory, including overnight stays

Job Responsibility

Build and maintain relationships with office-based and hospital nephrologists, pharmacists, nurses, and other relevant healthcare professionals
Develop a positive image of the company among key customer groups
Analyze the region to identify and develop centers specializing in rare diseases in nephrology
Provide educational and commercial services to physicians and pharmacies
Promote products in alignment with marketing and sales strategies while adhering to legal and compliance guidelines
Plan, organize, and execute local educational sessions for healthcare professionals
Collaborate cross-functionally with marketing, medical science liaisons, and other teams to ensure cohesive account management
Maintain accurate records in the CRM database and provide timely reporting to senior management
Collect and report pharmacovigilance information as per internal procedures
Represent the territory in reviews, account planning discussions, and at national/international events and congresses

Fulltime

Manager, Local Pharmacovigilance

AmerisourceBergen

Location:
Belgium , Mechelen

Category:
Consulting

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 25, 2025

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