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PV Coordinator
Job Description
(Target PR: 35-40/hr)
Drug Safety Associate
Responsibilities
- Ensure timely and accurate processing of adverse event reports in accordance with company policies and regulatory requirements
- Conduct thorough investigations and evaluations of adverse events, including reviewing medical records and collaborating with cross-functional teams
- Maintain a thorough understanding of product safety profiles and provide timely updates to internal stakeholders
- Monitor and analyze safety data to identify potential safety issues or trends and recommend appropriate actions
- Develop and maintain strong relationships with external partners, such as regulatory agencies and contract research organizations
- Assist with the development and implementation of pharmacovigilance processes and procedures
- Ensure compliance with all applicable regulations and guidelines related to pharmacovigilance
- Participate in cross-functional meetings and contribute to the development of risk management plans for products
- Support the preparation and submission of regulatory reports and responses to safety-related inquiries
- Collaborate with other departments, such as Clinical Development and Medical Affairs, to ensure the safety of products throughout their lifecycle
- Maintain accurate and up-to-date documentation of all pharmacovigilance activities
- Handling administrative tasks related to safety reporting, including filing, preparing cover letters, managing translations for required local languages, and completing submission forms as
- Working with minimal supervision, will oversee all aspects of pharmacovigilance (PV) safety reporting from project start-up through close-out, according to the agreed scope of work
- Participates in project teams, and where required provides training and support to team members in respect of safety reporting
Qualifications
- Education – bachelor’s degree or equivalent professional experience
- Previous experience of 2+ years of Pharmacovigilance / Drug Safety in a CRO or Pharma, Biotech environment.
- Preferably, experience of safety report distribution and submission, as well as healthcare administrative
- Training – Strong understanding of Good Clinical Practices (GCPs) and familiarity with global safety reporting regulations, including those from EMA, FDA, MHRA, other regions, and ICH guidelines
- Exceptional attention to detail with a focus on accuracy and meticulous
- Ability to multi-task, prioritize, and manage time effectively to handle multiple project assignments
- In-depth understanding of global and local pharmacovigilance (PV) regulations
- Understanding of medical terminology and familiarity with coding dictionaries g
- Experience with ArisG or a similar Safety Database a plus.
- Strong project management, interpersonal, verbal and written communication
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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