Pharmacovigilance Specialist - Maternity Replacement
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Company Description
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
This position is accountable for executing the day-to-day operations and compliance activities to maintain high functioning PV systems across assigned region.
Metrics and Oversight of the Pharmacovigilance System
Supports the provision of metrics that will ensure oversight of all aspects of the performance and functioning of the PV system in compliance with local regulations and internal company timelines/standards.
Quality Management System
Develops and maintains local/regional procedures in line with corporate procedures and local requirements.
Performs the impact assessment of new/updated corporate policies, process, and procedures.
Actively assists with the PV Exception Reporting/CAPA process.
Actively assists with the business continuity plan and testing.
Develops and maintains the local PSMF in line with AbbVie’s PV system master file, when required by local/regional regulations.
ICSR Management
Records, processes, and conducts follow up and translates adverse events and other safety information from spontaneous and solicited sources.
Performs ICSR expedited reporting according to the local requirements.
Ensures local-language medical or scientific literature review.
Implements an appropriate local quality control (QC) procedure to ensure quality of information entered and reporting decisions.
Completes AE reconciliation and ensures AE identification effectiveness sampling consistent with global procedures.
Periodic Safety Reporting
Leads the preparation of periodic safety reports (e.g., PSUR)., local annexes, local variations, and translation of safety deliverable documents.
Ensures submission of periodic safety reports and ensures documentation of evidence.
Audits and Inspection Management
Actively assists in managing internal PV audits, audits of affiliate service providers/third parties and Regulatory Authority PV Inspections.
Actively assists in the development of CAPA in response to observations and the tracking actions to completion in a timely manner.
Partnership with business partner with possibility for identification and/or handling of safety
information
Ensures all PV requirements are in place for activities where there is a reasonable possibility for the identification and/or handling of safety information in accordance with AbbVie procedures and local requirements.
PV Training
Ensures overall training compliance with corporate procedures and local PV requirements, including the maintenance of the PV Training Matrix and the development of additional PV training materials, as required.
Qualifications
1 year experience required within the pharmacovigilance or a related field,
Excellent command of written and spoken English; fluency in Romanian is mandatory, and proficiency in any additional language is a plus,
Effective communicator and able to work effectively in teams and a cross functional environment,
Strong commitment to compliance with relevant rules and procedures,
Effective planning and organizational skills, and the ability to complete activities with high quality,
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Job details
How this role compares
Computed from every other active Pharmacovigilance role in our database, not just this employer's listings.
We currently track 175 comparable Pharmacovigilance roles across 52 biopharma companies.
Salary context
42 of 175 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 175 comparable roles
+ 26 more countries
Seniority mix
115 of 175 peers have a known seniority level
Therapeutic area mix
22 of 175 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
Or follow a whole field: get every new Pharmacovigilance job in Romania, and choose locations and companies.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.