Senior Pharmacovigilance Safety Scientist, Benefit Risk

ProPharma; Berlin; Hybrid; EUR 70.000 - 100.000; Vollzeit

Zusammenfassung

ProPharma in Berlin is seeking an experienced Pharmacovigilance specialist to lead the preparation and review of safety reports and Risk Management Plans. The role includes literature screening, data extraction, and line listings, with mentoring of junior staff.

You will ensure compliance with regulatory standards and collaborate with clients to resolve issues while managing multiple PV activities in a hybrid work environment.

Qualifikationen

• 5+ years’ experience in Pharmacovigilance with a focus on Risk Management Plans.
• Experience presenting metrics and leading discussions about quality internally and with Client.
• Strong literature screening and regulatory safety reporting experience.

Aufgaben

• Authoring and quality review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ACO/DSUR) for submission to Health Authorities.
• Authoring and review of Risk Management Plans as part of PV activities.
• Authoring and quality review of Signal Management Reports.
• Conduct literature searches and validity checks for aggregate reports.
• Mentor and train junior staff as SME and trainer.
• Extract and validate data from safety databases and reports.
• Generate Line Listings and perform quality checks as needed.
• Support high priority ad-hoc PV activities.
• Interact with client personnel to resolve issues related to assigned activities.
• Ensure deliverables meet regulatory requirements and timelines.
• Plan and execute aggregate report preparation.

Kenntnisse

Pharmacovigilance

RMP knowledge

Literature screening

Regulatory compliance

Ausbildung

Bachelor/Master in Pharmacy or Life Science

Tools

Safety database

Line Listings

Jobbeschreibung

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Job responsibilities

• Authoring and Quality review of Aggregate reports (PSURs/PBRERs, PADERs/Annual Reports/ ACO/ DSUR) for submission to local and other Health Authorities.
• Authoring and review of Risk Management Plans (RMPs) as a part of regular Pharmacovigilance activities.
• Authoring and Quality review of Signal Management Reports.
• Performing literature search and validity check for the aggregate reports.
• Management and reconciliation of relevant process trackers.
• Subject matter expert (SME) along with training and mentoring of individuals.
• Extraction and validation of data (RSI, Sales, previous reports, RMP, signals).
• Generation of Line Listings (LL) from safety database and Quality check of the line listings when required
• Providing reliable support for high priority Ad-hoc activities.
• Literature (Clinical & non-clinical, scientific) validity check, duplicate search in the respective tool for literature review.
• Participating in internal/ external audits/ inspections as SME, if required.
• Interacting with appropriate client personnel to resolve issues related to assigned activities.
• Ensuring that deliverables to the clients comply with the relevant regulatory requirements and are sent to the client within agreed timelines.
• Independent planning and execution of tasks such as preparation of an aggregate report.

Experience Requirements

• 5+ years’ experience in Pharmacovigilance with a focus on Risk Management Plans.
• Bachelor/Master's Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience.
• Experienced in presenting metrics and leading discussions about quality internally and with Client.
• Well-rounded experience in literature screening activities and/or authoring and reviewing aggregate reports and/or experiences in authoring and updating RMPs and/or significant knowledge of signal detection methodologies and/or exp managing CCDSs and knowledge of regulatory safety variation processes

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.

Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.