Biotech and pharma firms face ever-tightening safety and regulatory requirements. Global vacancies in pharmacovigilance (PV) have surged: new safety-reporting standards mean companies are hiring record numbers of drug-safety associates, scientists, and analysts. At the same time, regulators such as the FDA and EMA are increasing scrutiny, so bigger PV teams are needed for case review, signal detection, and compliance. Stricter regulations and a booming drug pipeline have caused PV openings to skyrocket.

Similarly, Regulatory Affairs (RA) experts are in short supply. Industry data show a growing gap: open RA positions continue to increase year over year. In practice, this means you may compete with big pharma for a few high-quality RA managers or compliance officers – making it crucial to hire smart and early.

Key roles to prioritize include PV case processing associates, PV managers, medical reviewers, regulatory submission specialists, and quality/compliance leads. These hires must be detail-oriented and well-versed in guidelines such as GCP, MedDRA coding, and electronic safety systems. To build these teams, consider mixed approaches: combine full-time directors for strategic oversight with consultants to handle volume spikes.

Best practices include creating a pipeline of candidates through specialized recruiters and training programs. Focus on diversity of skills: PV roles now blend technical analysis with regulatory writing and global team coordination. By assembling a well-rounded, cross-functional team, companies can ensure compliance without gaps.

Meeting today’s PV and RA demands requires proactive hiring – leveraging expert partners, flexible engagement models, and targeted training to stay ahead of regulators.