Local Safety Officer
vor 2 Wochen
Local Safety Officer (Remote - Pharmacovigilance)
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title: LPPV
Location: Remote
Function: Drug Safety
DESCRIPTION:
LPPV works collaboratively with QPPV, other PV staff, and cross-functional colleagues/teams for pharmacovigilance activities and ensuring regulatory compliance according to the applicable regional and national laws for all medicinal product(s) and territory(ies) for which a company (MAH) holds marketing authorizations. The primary function is to maintain an oversight and management of pharmacovigilance activities, overseeing signal management and surveillance activities, management of responses to ad hoc regulatory responses, and literature review/management for safety findings etc.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Play primary role as Local Safety Officer for the assigned region and 24/7 availability for regulatory authorities.
- Ensure compliance with local guidelines and regulations applicable to MAH product portfolio.
- Support writing and compilation of various Aggregate Reports and regulatory filings.
- Perform review of reconciliation reports with Local Affiliates, Partner Companies, Call Centers and other internal departments/systems.
- Should have access to the reports of suspected adverse reactions and assist in monitoring the regulatory submissions.
- Manage end to end collection and processing of safety information for single case and aggregate report requirements.
- Ensure regular monitoring of local literature reviews.
- Manage relationships and communicate with local Health Authorities.
- Keep abreast of national pharmacovigilance and regulatory affairs regulations.
- Receive and handle medical information enquiries from patients and health care professionals.
- must be contactable at least during business hours.
- Have an oversight over national cases, signals, market research programs / marketing activities, studies, PSURs, RMPs and any risk minimization measurements and activities within their assigned region.
- Oversee national quality complaints and line listings with trends. If required, the LPPV will communicate potential recalls and coordinate together with the respective local authorities for any national recalls.
- Demonstrate knowledge and ensure compliance with current global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.), Sitero SOPs and quality standards.
- Stay current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA).
- Support inspection readiness activities and preparation as needed.
- Assist and participate in inspections and/or audits.
- Foster an environment of collaboration, team building, and continuous improvement.
EDUCATION AND EXPERIENCE REQUIRED:
- Degree in Medicine, Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in drug safety.
- Master’s or Doctorate level degree preferred.
PREFERRED SKILLS:
- Preference for a minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience.
- Competent knowledge of good pharmacovigilance practices. Competent knowledge of US and EU pharmacovigilance regulatory requirements.
- A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
- Experience in the review of relevant safety information from all sources and analysis of safety data.
- Experience with development, authorship, and review of aggregate reports (i.e., PSUR, DSUR, IND annual, NDA annual, etc.), Risk Management Plans, and Risk Evaluation and Mitigation
Strategies desirable.
- Knowledge of global clinical and post-marketing safety regulations, guidance documents, and reporting processes.
- Expertise with MedDRA, XEVMPD coding and safety database systems.
- Review and contribute to the development and implementation of new SOPs, work instructions, guidelines, documents and other tools pertaining to safety.
- Exhibit excellent organizational, presentation and communication (verbal and written) skills.
COMPENSATION & BENEFITS:
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits.
EMPLOYMENT TYPE:
Contractual, Need-basis
COMMITMENTS:
- Availability during business hours.
DISCLAIMER:
Sitero is an equal opportunity employer and welcom
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