Senior Pharmacovigilance Associate Job at iconplc (Sao Paulo)

Senior Data Scientist - Literature

Help bring science to life and join a leading pharmaceutical company to play a k...

Location

Switzerland , Basel

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Degree in medicine, pharmacy, or natural sciences
Experience in information science, particularly within pharmacovigilance and drug development
Strong knowledge of medicine, drug development, and biomedical literature databases
Proficiency in scientific data evaluation, interpretation, and synthesis
Excellent written and verbal communication skills, with the ability to explain search strategies effectively
Expertise in classical text searching and familiarity with literature sources and databases
Ability to build strong working relationships in a cross-functional, international environment
Self-motivated, detail-oriented, and capable of prioritizing tasks effectively
Fluent in English, both written and spoken

Job Responsibility

Conduct ad-hoc literature searches in biomedical databases to identify adverse drug reactions and risks associated with medicinal products and devices
Develop, test, document, and maintain search profiles for various safety and efficacy reports, including DSURs, PBRERs, and MDIRs
Ensure timely and accurate delivery of search results while adhering to standard operating procedures
Collaborate with internal stakeholders to define search criteria and maintain effective relationships
Review and validate the plausibility of literature search results
Actively contribute to the Safety Literature Group by sharing knowledge and best practices
Create and deliver training materials on retrieval and reporting topics for team members and stakeholders
Proactively identify opportunities to improve processes, methods, and technologies
Address and escalate any issues related to literature searches as needed

Associate Director, Integrated Pharmacovigilance Operations

Reporting to the Senior Director, Pharmacovigilance Operations, the Associate Di...

Location

United States , Waltham, Massachusetts; San Diego, California

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10 years of pharmaceutical experience with a demonstrated focus in PV operations and compliance
Thorough knowledge of relevant FDA and International Conference on Harmonisation (ICH) guidelines, including Good Clinical Practices (GCP) guidelines
Strong knowledge of global safety and pharmacovigilance regulations, guidelines, and industry standards (FDA, EMA, ICH, GVP)
Thorough understanding of Individual Case Safety Reports (ICSR) processing operations, including working with outsourced vendors and Contract Research Organizations
Demonstrated understanding of safety databases, medical literature, and electronic data capture technology
Working knowledge of validated drug safety databases and MedDRA coding dictionary
Skilled at negotiating with business partners or management and influencing senior level leaders regarding matters of significance to the department or more broadly within Kailera
Adept at communicating the pharmacovigilance and safety vision, effectively aligning activities and performance to achieve functional area goals in alignment with corporate goals
Bachelor’s degree or equivalent in Public Health, Life Sciences, or other relevant fields is required

Job Responsibility

Ensure compliance with global regulatory guidance and requirements (e.g., ICH, FDA, EMA, MHRA, TGA, etc.) and ICH-GCP/ICH-E2E guidelines to meet all applicable safety reporting requirements
Ensure that Individual Case Safety Reports (ICSR) and queries for assigned products are Reviewed for completeness and accuracy and submitted/distributed per global requirements and applicable SOP
Assist with data reconciliation and support safety signal management and aggregate data review activities
Contribute to the preparation and review of Safety Management Plans (SMP) for clinical trials
Support the continuous sponsor oversight of the global safety database and safety vendor activities with appropriate governance implementation
Assist with the development and implementation of innovative technical or procedural solutions to improve pharmacovigilance and safety operational capabilities
Assist in production and revision of pharmacovigilance and safety procedures, clinical trial documents and forms (e.g., IB, protocols, EDC CRF pages, etc.)
Contribute to regulatory filings and reviews (including BLAs/MAAs/INDs/CTAs), including responses to regulatory queries as needed
Represent pharmacovigilance and safety on project and study teams. Work closely with cross-functional team members to ensure accurate and efficient safety data collection
Work with quality assurance colleagues to address safety-related GCP/GVP compliance issues and support the implementation of corrective actions

What we offer

comprehensive health coverage
flexible time off
paid holidays
a year-end shutdown
monthly wellness stipend
generous 401(k) match
tuition reimbursement
commuter benefits
disability and life insurance
annual bonus opportunities

Fulltime

Senior GMP Quality Auditor

Proclinical is seeking a Senior GMP Quality Auditor to join a team in the UK. Th...

Location

United Kingdom , London

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Degree in Chemistry, Pharmacy, Microbiology, or equivalent
General auditing qualification: external lead auditing qualification is desirable
Proven experience in a similar role within the pharmaceutical industry
Familiarity with directives and guidelines for medical devices, sterile manufacturing facilities, and biosimilars
Strong organizational and time management skills with the ability to prioritize multiple tasks
Excellent communication skills, both written and verbal, including the ability to engage with senior management at third-party suppliers
Sound problem-solving skills and the ability to make decisions based on risk
Willingness and ability to travel globally
Proficient in working independently and collaboratively as part of a team

Job Responsibility

Mentor team members and support their professional development
Oversee the lifecycle management of approved vendors and suppliers in compliance with industry regulations
Establish and monitor KPIs, evaluating and reporting associated metrics
Manage a risk-based audit program for vendors and suppliers, excluding pharmacovigilance partners
Conduct risk analysis based on audit outcomes and collaborate with QPs and management on necessary actions
Ensure audits provide assurance for vendors and suppliers in line with EU GMP, EU GDP, or equivalent standards and marketing authorizations
Monitor and maintain CAPAs internally and with external suppliers
Maintain vendor validity within the SAP ERP system
Evaluate and interpret global regulations for audit purposes
Create, revise, and review QA documentation, including audit checklists, questionnaires, SOPs, and guidance documents

Fulltime

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 Manager, Global Medical Affairs (Menopause)

This role is pivotal in providing subject matter knowledge and expertise, develo...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Medical degree with GMC registration or equivalent international qualification or Master of Pharmacy with GPhC registration
Previous experience in Medical Affairs, Clinical Research, or Pharmacovigilance within the pharmaceutical industry
Very good understanding of Medical Affairs’ role as scientific enabler and strategic partner in a pharmaceutical company
Strong knowledge and subject matter in women’s health
Ability to cut through scientific complexity and to communicate precisely and clearly with different target audiences
Strong interpersonal and leadership skills and track record of expertise working in a cross-functional environment
Strong analytical and strategic thinking
Strong business acumen
Highest professional work ethics
Proven knowledge of the ABPI Code of Practice and codes of international associations of the pharmaceutical industry, with experience in reviewing and/or certifying materials

Job Responsibility

Develop and implement medical plans aligned with business objectives and manage associated budgets
Provide expert medical input across the product lifecycle, including: Evidence generation
Evidence dissemination (e.g. health care professional education programs)
Medical experts’ engagement programs (e.g. advisory boards)
Build and maintain relationships with international therapy area experts and medical-scientific professional societies
Act as a medical reviewer for promotional and non-promotional materials in line with the ABPI and international associations of the pharmaceutical industry codes as well as internal SOPs
Support regulatory and market access submissions with clinical content
Ensure compliance with all relevant regulations and contribute to continuous process improvement
Ensure operational excellence

What we offer

A fast-paced environment, with broad exposure, where you can develop professionally – even outside your area of expertise
We support you as you grow and learn, and we love to celebrate success and recognize performance
We provide opportunities for driven and talented professionals who want to be part of our exciting journey

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

New

Associate Director, Clinical Operations

We are seeking an Associate Director, Clinical Operations who will be accountabl...

Location

United States

Salary:

180000.00 - 195000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

BA/BS in life sciences or equivalent
8+ years of clinical research experience, including at least 3 years leading global projects from inception to completion
2+ years’ experience in Biotech industry strongly preferred
Significant knowledge of pharmaceutical industry, drug development and regulatory processes
Experience developing all Clinical trial plans, including site management, risk assessment and mitigation strategies, recruitment and retention plans, trial budgets and program-level budgets
Leader with growth mindset, willing to learn from others, committed to mentoring others and dedicated to promoting psychological safety
Strong communication skills with ability to present to a variety of stakeholders and tailor message accordingly
Strong project management skills with ability to collaborate effectively cross-functionally and hold team and CRO members accountable to tight timelines and budgets
High sense of urgency and ability to proactively identify critical path items and develop contingency plans to mitigate risk to budget, quality, and/or timelines
Work comfortably in a fast-paced, dynamic work environment and embrace change

Job Responsibility

Accountable for overall management of multiple clinical trials
Serves as the central point of contact and contributes expertise for clinical trial execution on assigned protocols
Works cross-functionally to establish and ensure clinical program timelines and goals are met and risks are appropriately escalated to Clinical Management. Ensures accurate tracking and reporting (dashboard) of study metrics and progress of study through completion
Leads the Clinical Study Team (CST) and may participate in other cross functional program team meetings
Ensures trial adherence to ICH/GCP/Federal and local regulations and company specific SOPs
Responsible for preparing and/or presenting to executive management as delegated
Develops, reviews and/or consults on clinical trial documents, such as study specific plans, informed consent, clinical protocols, Investigator Brochure, CSRs, yearly updates to the regulatory authorities and status updates
May be responsible for participating and presenting at Investigator Meetings, SIVs and other program meetings
Responsible for study level clinical operations budget forecasting, accrual management and quarterly review ensuring tight control between study forecasts and actuals
In conjunction with key stakeholders, oversee and manage the execution and filing of site clinical trial agreements, review of fair market value, CRO and vendor contracts, NDAs, etc

What we offer

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

New

Data Scientist

As a Data Scientist, your primary responsibilities will include: Data Collection...

Location

United States , Atlanta

Salary:

142000.00 - 200000.00 USD / Year

Helpcare AI

Expiration Date

Until further notice

Requirements

Bachelor's or Master's degree in a quantitative field, such as Computer Science, Statistics, Mathematics, or Data Science
Proven experience in data collection, cleaning, and preprocessing using tools like SQL, Python, or R
Expertise in statistical analysis, machine learning, and predictive modeling techniques
Strong problem-solving skills and the ability to translate data insights into actionable recommendations
Excellent communication and presentation skills, with the ability to effectively collaborate with cross-functional teams
Experience in the health or wellness industry, particularly in the context of addiction or behavior change, is preferred
3+ years experience
US citizen/visa only

Job Responsibility

Collaborate with the engineering team to establish robust data collection pipelines, ensuring the integrity, security, and accessibility of user data
Design and implement data warehousing and storage solutions to efficiently manage the growing volume of user data
Develop data quality assurance processes to maintain the accuracy and reliability of the data
Implement robust data cleaning and preprocessing techniques to address issues such as missing values, outliers, and data inconsistencies
Develop automated data transformation and normalization pipelines to ensure the data is in a format suitable for analysis
Work closely with the engineering team to streamline the data cleaning process and maintain the integrity of the data
Conduct in-depth analyses of user behavior, engagement, and outcomes to uncover patterns, trends, and opportunities for optimization
Leverage statistical techniques and machine learning models to identify the key factors influencing user success in reducing alcohol consumption
Generate insightful visualizations and dashboards to communicate findings to cross-functional stakeholders
Develop predictive models to anticipate user needs, behaviors, and potential risk factors related to alcohol consumption

Fulltime

Senior Pharmacovigilance Associate

iconplc

Location:
Brazil , Sao Paulo

Category:
Health and Beauty

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 20, 2026

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