Manager, Local Pharmacovigilance Jobs

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

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

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Non-Pharma Global Regulatory Affairs Manager

The Global Regulatory Sciences-Legacy Products-Non-Pharma Manager manages regula...

Location

Italy , Bologna; Milano; Pomezia

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Proven experience in Regulatory Affairs within the pharmaceutical or life sciences industry, preferably within the food supplements, medical devices, and cosmetics sectors
Hands-on experience with regulatory submission processes, especially within EU and/or RoW markets or similar relevant experiences
Demonstrated ability to coordinate projects or deliverables with complexity and limited supervision
Advanced degree in Life Sciences, Pharmacy, Chemistry, or a related field
Good knowledge of global regulatory frameworks including EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
Strong organizational skills, attention to detail, and ability to manage priorities
Collaborative mindset and effective communication with team members and stakeholders
Ability to operate independently on clearly defined assignments
Proficiency in Microsoft Office Suite and regulatory submission/document management tools
Fluent in English, both written and spoken

Job Responsibility

Accountable for providing the necessary regulatory inputs in a cross-functional team for the development of new projects
Accountable for the execution and implementation of global regulatory strategies by managing day-to-day activities for assigned products
Manage multiple regulatory workstreams independently, including authoring, reviewing and coordinating documentation for regulatory submissions such as variations, renewals and geo-expansions
Provide and review regulatory assessments for change controls and product updates
Responsible for the preparation, review and collection of documentation for submission and maintenance of Technical File and PTD for the project assigned
Provide critical review of documentation supporting regulatory applications
Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
Contribute to the preparation and presentation of regulatory project updates in internal meetings and governance committees
Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
Support other relevant assignments as directed by supervisor

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Associate Director, Pharmacovigilance Scientist

The Associate Director, Pharmacovigilance Scientist will provide leadership, gui...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting with a Bachelors degree or 5+ years of experience with an advanced degree
Experience in safety data analysis, signal management, and benefit-risk evaluation
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding
Experience with authoring or contributing to aggregate safety reports, signal assessment reports
Working knowledge of relevant local and global regulatory requirements and guidance documents
Experience in creating or managing SOPs or Work Instructions
Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities
Strong ability to work independently and collaboratively with internal and external partners in a demanding environment
Ability to prioritize, multitask, and deliver quality results that meet tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly

Job Responsibility

Perform and coordinate complex benefit-risk assessment and safety surveillance activities
Serve as a critical contributor to the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings
Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable
Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections
Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad-hoc safety reviews
Perform safety signal management activities
conduct signal detection, author signal validation/evaluation reports, track and communicate findings
Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews
Lead or assist with the preparation of Risk Management Plans (RMPs)

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Ruminant Product Manager

We are looking for a 'Ruminant Product Manager' for our global leader partner op...

Location

Turkey , Istanbul

Salary:

Not provided

Randstad

Expiration Date

February 28, 2026

Requirements

Bachelor’s Degree
Strong communication skills both in Turkish and English
written, verbal and presentation skills
Minimum 3 years product management experience
A scientific background
experience or interest in science
Exceptional relationship management, interpersonal skills and influencing abilities
Effective stakeholder management
Experience working with digital technology
A strong working knowledge of all key marketing disciplines and techniques

Job Responsibility

Lead the development of annual strategic marketing plans for core products
Work with field force to ensure alignment of marketing programs to the Business Unit marketing strategy, sales activities and account plans
develop, review and revise sales forecasting and inventory management
Conduct respective monthly reports meetings
Determine the appropriate pricing structure together with Business Unit and Commercial Operations leaders to maximize sales and profitability
Maintain expertise with the evolving portfolio of products, services, pricing, competition, market and industry trends
Conduct regular customer visits to gain customer insights
Use this knowledge to feed into marketing plans
Develop and deliver marketing campaigns that achieve appropriate impact, product positioning, market growth and profitability
Provide support, guidance and training to sales teams to ensure that all marketing activities are well-aligned with marketing priorities and objectives for each product and campaign

Territory Manager Hungary

Under the direction and guidance of the Sales Lead-Associate Director EEC, the T...

Location

Hungary

Salary:

Not provided

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Pharmacist or MD or BS/BA degree in life sciences
Minimum of 5 years Sales-experience in the pharmaceutical or Biotech sector
Experience in innovative product-areas, preferred for hospital drugs in specialist indications
Experience with rare diseases highly desirable
Good skills in English as well as effective communication skills in the local language
Familiarity with basic regulatory requirements, particularly sales and marketing activities as well as pharmacovigilance
Good understanding of Health Care Systems including financing and public health policy
Flexible, dedicated, ability to recognize customers’ needs, open in communication
Commercial and customer-oriented thinking
Ability to discuss problems and solutions with KOLs, and scientific societies

Job Responsibility

Contribute to the definition of the strategy, goals, forecast and budget in the country
Collaborate in the definition and implementation of the strategy for maximizing the goals for the country, developing competencies and processes as required to create effectiveness and efficacy
Manage the territory in a selling range of designated products, planning the use of resources in medium and long-term to meet targets e.g. budget, human resource and product planning
Define and oversee activities related to marketing and promotion of BioMarin products in the county
Provide support to the market access activities in the country, including national and regional price/reimbursement negations
Work closely for relationship management, institutional relations, Patients’ Groups and KOL engagement
Work collaboratively with Central Functions as appropriate
In accordance with company standard requirements, report any adverse event or any safety information associated with a BioMarin product
Distribution of educational materials to Healthcare Professionals
Document distribution of materials to, and confirmation of receipt of materials by, the Healthcare Professionals

New

Product Design Engineer

Seeking a Product Design Engineer (Product Engineer) for a full-time position wi...

Location

United States , Jackson, Michigan

Salary:

Not provided

GlobalEdge Technologies

Expiration Date

Until further notice

Requirements

Proficiency in CATIA V5
Proficient in use of analysis tools and application of boundary conditions, constraints, and application of loads
Ability to read and understand Drawings, Specifications, and Requirements
Working knowledge of Geometric Dimensioning and Tolerancing (GD&T)
Understanding of design evaluation techniques such as reliability analysis, statistical tolerance stack up, Failure Mode and Effect analysis (FMEA), etc.
Proficiency in Product Data Management systems for document control and workflow management (ENOVIA is a plus)
Ability to compose clear and concise technical communication
Bachelor’s degree from accredited institution in engineering required. (Mechanical or aerospace discipline preferred.)
5 years’ experience in a product design and development engineering

Job Responsibility

Execute internal and customer technical deliverables on high complexity projects within the PRE/PROLaunch development process through the use of the Aerospace Common Engineering Standards
Drive the design and develop new products or re-design current products to meet customer requirements via cross functional collaboration with customers and an internal team including Manufacturing, Quality, Supply Chain, Program Management as well as product or process subject matter experts
Identify project technical and schedule risks, prioritize based on quantified impact, and execute mitigation plans
Evaluate design trade-offs using Design for Six Sigma tools
Support creation and execution of product development plans to meet customer requirements and quote the labor, material, and other direct costs (MODC) required to execute the development and qualification programs, addressing technical risks prior to qualification
Apply statistical and analytical tools towards effective problem-solving and completion of project activities
Aid in directing and reviewing work performed by engineering resources within Company's functional Centers of Excellence (COEs) for timely completion of project objectives
Support structured problem solving efforts and/ or failure analysis to solve issues in a timely manner
Conduct internal, supplier, and customer design reviews
Support or author qualification procedures defining instrumentation strategies and test setup detail in conjunction with the test engineering. Must be fully knowledgeable about sampling rates, noise sources, grounding, and filtering

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

Looking for more opportunities? Search for other job offers that match your skills and interests.

Similar Jobs for Manager, Local Pharmacovigilance