Drug Safety Associate Director

Job Description An amazing opportunity has arisen for a Drug Safety Associate Director , Pharmacovigilance (PV) within International Pharmacovigilance (IPV). This position plays a critical role in overseeing local PV processes and day‑to‑day adverse event case management across ex‑US markets, ensuring adherence to applicable regulations, company policies, and procedures. Reporting to the Director PV Lead, the Drug Safety Associate Director may serve as the designated back‑up for the local Local PV Contact / Local Responsible PV person, managing local PV activities in the PV Lead’s absence and representing PV in cross‑functional and external forums. What you will do Oversee and execute local PV processes and activities, aligning with local legislation and company procedures; manage local PV agreements, due diligence, PSMP implementation, aggregate report scheduling, training, and safety communications. Support audits and inspections (readiness, conduct, CAPA development) and participate in issue management/compliance activities, including local corrective actions and PV self‑inspections. Maintain and develop local PV procedures and controlled documents (e.g., SOPs, training materials). Ensure implementation and oversight of Risk Minimization Measures and local RMP activities. Monitor Health Authority websites for safety issues, alerts, and new/revised PV requirements; liaise with local business units to provide PV input on strategic decisions; represent PV in cross‑functional forums. Serve as back‑up to the PV Lead when designated, acting as local SME, point of contact for Health Authorities, fulfilling procedural tasks, escalating safety/security issues, and contributing to PV‑impacting strategic decisions. Represent PV in cross‑functional and external forums, supporting strategic decisions and local initiatives. What skills you will need In order to excel in this role, you will more than likely have: A degree in health, life sciences, or medical sciences, or equivalent education/experience. At least 4 years’ experience in the pharmaceutical industry; experience supervising people/teams/contractors is preferred if managing staff. In‑depth knowledge of adverse event reporting requirements, PV regulations, PV quality systems, and expert‑level PV process knowledge. Proven experience with PV audits and/or Health Authority inspections. Fluency in English (written and spoken) and proficiency in the local language. Open to travel (0–5%). Exceptional interpersonal communication, organization, presentation, negotiation, and influencing skills. Strong cross‑functional collaboration capability and the ability to work independently, manage multiple priorities and lead change. Demonstrated ability to drive process improvements that enhance quality and add business value; strong strategic thinking. Advanced project management skills, including prioritization and coordination across multiple initiatives. Required Skills Adaptability Adverse Event Report Auditing Audit Inspections Business Continuity Business Decisions Clinical Research Communication Compliance Monitoring Data Management Global Program Development Interpersonal Communication Leadership Life Science Management Process Medical Affairs Organizational Performance Management Pharmaceutical Management Pharmaceutical Regulatory Compliance Pharmacovigilance Process Improvements Regulatory Compliance Regulatory Reporting Risk Minimization …additional skills Preferred Skills Preferred skills were not listed in the original posting. Why Join Us? We keep the patient at the very heart of our work and strive to find solutions and treatments for some of the world's most challenging healthcare needs. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. Apply Today So, if you are ready to lead local PV excellence across diverse markets, act as a trusted SME and back‑up PV Lead, and help us advance patient safety with rigor and integrity—please apply today. Current Employees Apply Current Employees apply HERE Current Contingent Workers Apply Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre‑existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Job Posting End Date: 02/1/2026 Please ensure you apply to a job posting no later than the day before the job posting end date. #J-18808-Ljbffr