Senior Pharmacovigilance Safety Scientist, Benefit Risk

ProPharma Group; Philippines; On-site; PHP 70,000 - 110,000; Full time

Benefits offered by this job

Hybrid work model

Equal opportunity employer

Job summary

ProPharma Group is seeking a Pharmacovigilance specialist with 4+ years of experience to support RMPs, aggregate reports, and literature reviews for regulatory submissions.

The role involves authoring PSURs and other safety reports, quality reviews, and collaboration with clients. Hybrid work arrangements and opportunities for mentoring are available.

Qualifications

• 4+ years’ experience in Pharmacovigilance with a focus on Risk Management Plans.
• Experience presenting metrics and leading internal and client quality reviews.
• Solid literature screening and/or authoring/review of aggregate reports and RMPs.
• Knowledge of signal detection methodologies and CCDS management.
• Ability to interact with client personnel and support audits/inspections.
• Bachelor/Master’s Degree in Pharmacy, Nursing, Life Science or related field.

Responsibilities

• Authoring and quality review of PSURs/PBRERs and other aggregate reports for regulatory submission.
• Authoring and review of Risk Management Plans as part of pharmacovigilance activities.
• Literature checks and validity verification for safety reports.
• Manage trackers and data extraction for RSI, sales, and reports.
• Provide SME support, training, and mentoring to team members.
• Assist in internal/external audits and client communication.

Skills

Pharmacovigilance

Risk Management Plans

Literature screening

Data extraction

Quality review

SME training

Client interaction

Education

Bachelor/Master in Pharmacy, Nursing, Life Science

Job description

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.

Key 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.
• Other duties as assigned.

Bachelor/Master's Degree in Pharmacy, Nursing, Life Science, or other health-related field, or equivalent qualification/work experience.

Experience Requirements

• 4+ years’ experience in Pharmacovigilance with a focus on Risk Management Plans.
• Experiences in presenting metrics and leading discussions about quality internally and with Client.
• Well-founded 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.

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.