Senior Pharmacovigilance Specialist is responsible for supporting global and local PV systems and ensuring compliance with all PV activities with international or local regulations. May overtake additional regional or local PV responsible person roles for simple PV systems.
The position is remote, home-based in any EU country.
All CVs must be submitted in the English language for consideration.
Responsibilities:- Act as the Project Manager or deputy Project Manager for the assigned projects
- Perform accurate forecasting and contribute to budget planning, ensuring efficient functioning of the QPPV Office
- Update SOPs and act as a subject matter expert for PV in assigned company processes
- Maintain KPI reports and perform core and standard PV activities for assigned contractual partners.
- Manage Full or local Pharmacovigilance systems and projects (or part of them) and/or central pharmacovigilance activities (e.g. end-to-end case processing, Aggregate Safety Reports, Risk Management Plans and risk minimization activities) in both pre- and post-authorization setting (as applicable)
- Act as a customer contact point (where applicable), ensuring consistent communication and escalation management across assigned projects
- Act as the appointed EU QPPV or deputy EU QPPV in accordance with a separate QPPV Job Description (if applicable)
- Ensure high-quality performance of PV services in assigned region/country and timely communication with Health Authorities
- Ensure inspection/audit readiness and finding remediation
Requirements
- Biologist, Pharmacist, Medical Doctor, or other life science degree
- 4-year experience in global Pharmacovigilance activities
- Fluent English
- Computer literacy (MS Office), experience with PV databases (Veeva Vault Safety experience is an advantage)
- Strong organizational and time management skills
- Ability to work independently and in a team
- Strong organization, prioritization, and time management with reliable delivery of commitments
- Strong communication and relationship building skills across functional teams
Benefits
- Professional growth and career opportunities
- International team and environment
- Bonus based on annual performance
- Personal accident and business trip insurance
- Additional health insurance
- Remote/home based
- Rewarding referral policy
- Workplace establishment allowance (fully remote)
- Team building, global meetings, B active events
Skills Required
- Degree in Biology, Pharmacy, Medicine, or another life science field
- Four years of experience in global pharmacovigilance activities
- Fluent English
- Computer literacy, including MS Office
- Experience with pharmacovigilance databases
- Veeva Vault Safety experience
- Strong organizational, prioritization, and time-management skills
- Ability to work independently and as part of a team
- Strong communication and relationship-building skills across functional teams
What We Do
Biomapas is a functional and full outsourcing solution provider to the global life science industry. As a trusted partner for biopharmaceutical, medical device, cosmetics, and food supplement companies, we have one-stop-shop clinical research capabilities in high recruiting countries, delivering regulatory and pharmacovigilance excellence across Europe, CIS, MENA, and LATAM regions through the entire product lifecycle. Our in-house experience combined with a hands-on mindset allows for tailored solutions to complicated challenges that emerge on your path to commercialization. Our professionals execute your projects efficiently, cost-effectively and aspire to partner with you and become an integral part of your team from Early Development to Commercial success. We keep our promises. Always. Social media privacy policy: bit.ly/privacy-biomapas
