Senior Pharmacovigilance Officer, Team Lead
3 semanas atrás
Senior Pharmacovigilance Officer, Team Lead (HCP & Clinical Trial Experience)
Company Overview
PrimeVigilance, part of the Ergomed Group, is a specialised mid‑size pharmacovigilance service provider founded in 2008. With a global presence across Europe, North America and Asia, we deliver services in Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. We support pharmaceutical and biotechnology partners, covering all therapy areas including medical devices, and we invest heavily in training, career development and employee wellbeing. Our team values diversity, equity and inclusion, creating an equal‑opportunity workplace for all cultural backgrounds, genders and ages.
Job Description
Key Responsibilities:
- Lead the team responsible for ICSR management for assigned projects as Team Leader.
- Ensure tasks are adequately distributed and oversee workflow processes.
- Cooperate effectively with clients in ICSR management.
- Provide support to other project activities on behalf of the client and the company.
- Line‑manage assigned ICSR staff.
- Create and maintain project‑specific KPIs, optimising procedures, training and actions to increase team efficiency.
- Propose process changes to the ICSR Operational Lead.
- Manage ICSR deviations with support from the ICSR Operational Lead.
- Review trackers and timesheet data, ensuring accuracy.
- Participate in ICSR processing and conduct 2nd quality checks of cases.
- Act as the team SME, supporting other SMEs.
Qualifications
Required: Life science graduate, physician, pharmacist, or other healthcare‑related qualification with experience in pharmacovigilance.
Preferred: Extensive experience in pharmacovigilance and clinical trials, including a demonstrated line‑manager role.
- Excellent written and verbal communication skills.
- Strong organisational skills with attention to detail and multitasking.
- Delegation and planning abilities.
- Time‑management skills.
- Technical proficiency.
- Team‑working mindset.
Additional Information
PrimeVigilance is committed to diversity, equity, and inclusion, fostering a human‑centric environment. Employee well‑being and work‑life balance are priorities.
Benefits and Development
- Training and career development opportunities.
- Strong emphasis on personal and professional growth.
- Friendly, supportive working environment.
- Opportunity to collaborate with colleagues worldwide, using English as the company language.
Core Values
- Quality
- Integrity & Trust
- Drive & Passion
- Agility & Responsiveness
- Belonging
- Collaborative Partnerships
Position Details
Seniority Level: Mid‑Senior level
Employment Type: Full‑time
Job Function: Legal
Industries: Pharmaceutical Manufacturing
Location: Porto, Portugal
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