Safety & Pharmacovigilance Specialist Job at Piper Companies (Bethesda)

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

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)

Patient Safety Associate II/Patient Safety Specialist - Japanese

Patient Safety Associate II/Patient Safety Specialist - Japanese role at Parexel...

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Sound knowledge of drug safety and the drug development process
Knowledge of and ability to interpret and apply global safety regulations
Experience in data analysis and evaluation of safety data
Good presentation skills
Analytical and problem-solving skills
Clear understanding of the regulatory submission process
Proficient in database/literature searches
Excellent interpersonal skills
Excellent verbal / written communication skills
Excellent organizational and prioritization skills

Job Responsibility

Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, and SOPs, and Global drug safety regulations
Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
Assist in development of project specific safety procedures, workflows and templates
Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
Delegate work as appropriate to Drug Safety Assistants
Liaising and collaborating with the relevant function at the client’s end to facilitate the delivery of high-quality work
Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
Mentoring new recruits in the team, if required
Archiving the source documents and relevant emails as required

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

Drug Safety Specialist

Are you an expert in Drug Safety seeking a flexible, freelance opportunity in an...

Location

Germany , Berlin

Salary:

85.00 - 130.00 EUR / Hour

Randstad

Expiration Date

Until further notice

Requirements

Degree in Pharmacy, Medicine, Biology, or a related discipline
Several years of professional experience in Pharmacovigilance and Drug Safety
Comprehensive knowledge of Good Pharmacovigilance Practice (GVP), ICH Guidelines, and national/international regulations
Analytical mindset and high degree of accuracy
Excellent communication skills in english

Job Responsibility

Support our client's team with the monitoring, documentation, and assessment of drug side effects

Case Management – Specialist (Device Safety)

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 4 years of Drug Safety or Life Sciences experience
Master’s degree and 7 years of Drug Safety or Life Sciences experience
Bachelor’s degree and 9 years of Drug Safety or Life Sciences experience
Pharmacovigilance, or Quality experience in biotech, pharmaceutical or medical device industry
Bachelor’s Degree in a health-care subject area or scientific field
Previous experience with a corporate intake system or safety database
Ability to successfully manage workload to strict timelines
Familiarity with basic project management tools
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment

Job Responsibility

Support interactions with business partners (license partners) and vendors for all case intake and processing activities
Vendor oversight of all case intake and processing activities and case quality including analysis and reporting of trends in quality measures
Ensure vendor compliance with approved processes and training requirements
Submission of all individual case safety reports to FDA/EMA, business partners (license partners), and vendors
Act as US/EU local safety office and FDA/EMA point of contact for safety reporting
Provide audit & external inspection support
Accountable for quality of device/combination product Individual Case Safety Reports (ICSR) processing globally for clinical trial and post-market cases
Ensure Vendors deliver high quality device/combination product cases through metric management and meet all worldwide regulatory authority requirements
Provide vendors with resources and training to perform their role
Responsible for raise of device/combination product case related issues

What we offer

Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards

New

Senior Pharmacovigilance Specialist

The Local Pharmacovigilance Specialist is responsible for the execution of tasks...

Location

Ukraine , Kyiv

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Professional education or University degree in Life Science preferred but not essential
Basic understanding/knowledge in the field of pharmacovigilance and medical information
Ability to prioritize and manage own time and tasks
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 point out issues and provide potential options for solution in the area of expertise
English business fluent

Job Responsibility

Data entry and quality control of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature
reporting of ICSRs to the competent authorities
Support in the generation, processing, documenting, and tracking of follow-up requests
Screening and documentation of scientific literature regarding safety relevant publications
Assist in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), risk management plans and signal detection reports
Interact with customers as needed (e.g. meetings, client visits, day to day case processing, etc.)
PSMF maintenance
Contribute to/review QA documents such as Working Instructions, SOPs, Working Procedures, templates, project metafiles, etc. for pharmacovigilance projects
Prepare for and participate in internal and external audits/inspections
Training new colleagues in relevant tasks

Fulltime

Consumer Excellence Specialist

Karo Healthcare, a dynamic and growing personal-care retail company, is all abou...

Location

Sweden , Stockholm

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

Experience in consumer support, customer care, or complaint handling, ideally within FMCG, consumer health, skincare, or regulated environments
Strong written and verbal communication skills with a clear, empathetic, and professional approach
High attention to detail and strong organisational skills, especially when handling complaints and safety-related information
Comfortable working across multiple channels such as email, social media, and third-party platforms
Collaborative mindset with experience working in cross-functional and outsourced team setups
Understanding of Pharmacovigilance requirements and the importance of compliance in consumer-facing activities

Job Responsibility

Respond to consumer enquiries across email, social media, and third-party platforms with accuracy, empathy, and professionalism
Act as a trusted point of contact for product and brand-related questions
Ensure a consistent, high-quality tone of voice across all consumer touchpoints
Log consumer complaints and feedback accurately in Veeva, in line with internal processes and regulatory requirements
Identify and escalate adverse events and potential safety concerns to Pharmacovigilance and Quality teams in a timely manner
Take ownership of complex cases, ensuring clear communication and end-to-end resolution
Work closely with cross-functional teams including Quality, PV, Marketing, and Regulatory Affairs to resolve consumer issues
Support and collaborate with outsourced consumer service partners to ensure consistent service quality
Share consumer insights and feedback to support product, process, and experience improvements
Represent a portfolio of Established and Digestive Health brands, adapting communication style to each brand's tone and audience

What we offer

Opportunity to create, grow, and encourage
Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
Flexible schedule, hybrid model with the primary work place in the office, and life-work balance
Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
Very positive work environment in a dynamic, international, and motivated team
Start-up spirit while being a part of the large international organization with strong values

Fulltime

Safety & Pharmacovigilance Specialist

Piper Companies

Location:
United States , Bethesda

Category:
IT - Administration

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
February 19, 2026

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