Global PV Specialist 100% (m/f/d)

Reporting to the Director PV Operations. Global PV Specialist is the key contributor focusing on operational support for all Arcera products throughout the life cycle. Global PV Specialist/Sr. Global PV Specialist is responsible for the management of Global literature and regulatory search and other operational tasks.

Key Responsibilities: 

1. Global literature search:

• Establishes literature search processes: Creates and implements robust search strategies for scientific and medical literature to identify individual case safety report, potential safety signals and PSUR relevant safety information.
• EMBASE search strategy development: EMBASE query creation, execution and maintenance.
• Literature outputs monitoring: Systematically monitors EMBASE outputs for relevant safety information.
• Triage and Evaluation: Classifies search results and critically evaluates all detected safety information (e.g., case reports, interventional and observational studies, meta-analyses) to determine their relevance to the company's products.
• Documentation: Ensures that all literature monitoring activities are meticulously documented and traceable for audits and inspections.
• Quality check: Does periodical quality check of other reviewer selected search results to ensure quality requirements are met.
• Proactively checks the literature screening processes and proposes and implements improvements if applicable.

2. Global regulatory search

• Screens all relevant Competing Authorities websites for safety data.
• Triage of relevant safety findings (e.g., emerging safety issues, new valid/potential signals, referrals, etc.) to determine their relevance to the company's products.
• Archives result of regulatory search.

3. Operational support/management:

• Supports Global PV Operations: ensures filing and archiving PV documents, maintenance of Global Trackers/Folders, organizes and participates in PV meetings, workshops.
• Supports other Global PV functions and processes.
• Supports local PV processes within PV network.
• Performs other tasks under direction of Director PV Operations.

4. SOP Management:

• Identifies the need for new PV procedures and SOPs, participates in development, revision and Implementation.
• Ensures up to date internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at pharmacovigilance and other drug safety training.

5. Inspection and audits:

• Cooperates with QA regarding PV compliance and inspection readiness.
• Participates in inspection and audits.

Key Skills:

• Scientific & Technical & Compliance Knowledge
  • Very good knowledge of PV requirements, processes, procedures & pathways.
  • Determines PV requirements (local, national, international), options for regulatory.
  • Understands PV processes and roles and responsibilities according to the PV and other agreements.

• PV network and Strategy
  • Capacity to integrate the broad picture as well as detailed analysis.
  • Evaluates the PV regulatory environment and contributes to providing internal advice and regulatory information throughout the product lifecycle to ensure product compliance.
  • Works with cross-functional teams in interactions with regulatory authorities.

• Business mindset, strategic planning and thinking
  • Understands company strategy and goals and turns them into actions.
  • Continually improves the quality of policies and services provided.
  • Participates in stakeholder groups to shape strategy and science-based decision making.
  • Identifies the gaps in processes and solve them according to the regional/local requirements.

• Behavioral & Soft skills
  • Fix all competencies needed for delivering consistent results with sustainable growth.
  • Very good presentations and communications skills.
  • Problem solving - chooses the best alternative to achieve desired outcome or effect, giving consideration to risks, timing and available resources.
  • Willingly accepts challenging assignments and new career opportunities that stretch and build capabilities.
  • Acts in line with Arcera behaviors and values.

Qualifications & Experience: 

• A master's degree in a life science field is required. A degree in pharmacy, medicine, or biomedical sciences is preferred.
• Minimum 3-year of experience in a pharmacovigilance, ideally in the role focused on aggregate reports preparation or literature surveillance.
• Very good presentations and communications skills.
• Advanced user of MS Office applications (Word, Excel, PowerPoint, Outlook)
• Experience with electronic systems and databases 
• Fluent in both written and spoken English is a must