Job Description
The Senior PV Scientist serves as a critical medical analytic and coordinating role in partnership with the Safety MD/Medical Monitor for assigned marketed and/or investigational product(s). The Senior PV Scientist is expected to be equally effective in working collaboratively or independently. She/he must demonstrate effective leadership skills with cross functional partners to ensure that signaling, safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines. For investigational products, this role may also participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. The Senior PV Scientist also plays a key role in ensuring that the above activities remain compliant with evolving regulations, that respective SOPs and work instructions regarding signaling, ad hoc and aggregate safety and risk management reports are adequate.
The successful candidate will have demonstrated successful mastery of the above responsibilities in their work. Accountability and a sense of urgency in leading/managing projects is a key success factor for this role. Demonstrated ability to assimilate clinical data, and through its analyses/review be able to make crisp assessments and be able to communicate this effectively both verbally and in writing plays a critical capability in this job.
This position will report to the Principal Scientist of DSPV.
Responsibilities For assigned product(s):
- Coordinate and document ongoing safety surveillance activities with the safety physician. Activities will include safety data review, signal validations, signal evaluations
- Lead aggregate report (PSUR/PADER/DSUR) activities, including vendor oversight and project management, database requests, data analysis, report authoring, and quality checks
- Manage literature review plan for assigned product(s) and provide feedback to vendor on routine literature surveillance activities
- In collaboration with the safety physician, prepare materials for routine and ad hoc Safety Governance meetings (product- and leadership-level meetings)
- Coordinate responses for ad hoc safety queries (eg, health authority requests, NISS, or health hazard evaluations) in collaboration with the safety physician and cross functional team members, as needed. Perform safety data analyses, draft query responses, and prepare documents for cross functional review and finalization
- Represent safety (with safety physician) and cross functional product meetings
- For investigational product(s): Support activities relevant to investigational program including (but not limited to):
- Routine/ad hoc updates to safety content of Investigator Brochure (IB), safety content of protocols, CRFs, ICFs
- Routine DSMB presentations
- Ongoing data review, including lab, vitals, ECG, and AE data review
- Review preliminary data and prepare presentations for safety review committees
- Maintain strong working knowledge of relevant regulations associated with the above activities
- Contributes to initiatives for process improvement and cross-product process consistency
- Other tasks as assigned or required
Qualifications - Minimum 5 years relevant medical, scientific/clinical, or pharmaceutical experience, including 3 years of experience in drug safety serving in a PV Scientist role
- Demonstrated experience in analysis and interpretation of medical and scientific data and excellent verbal and written skills
- Demonstrated ability to work effectively either independently or collaboratively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues
- Demonstrated ability to prioritize multiple assignments and proactively identify solutions, as needed
- Strong organizational, project management and leadership skills: Leads and conducts (independently and/or collaboratively) all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests. Oversees and mentors less experienced PV Scientist staff
- Scientifically sound and clinically accurate approaches to interpret data involving patient safety.
- Familiarity with pharmacovigilance and drug development, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes familiarity with case processing, expedited reporting rules, and safety database concepts
- Strong knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects), MedDRA, and Argus Safety System
Education:
- Advanced degree (PharmD, RN, MD, PhD, MPH, NP)
Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.
The annual base salary for this position ranges from $145,000 - $158,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website:
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About Us Why join Team Alkermes? Alkermes applies its decades of deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we seek to make a meaningful difference in the way people manage their diseases. We have a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy, and a pipeline of clinical and preclinical candidates in development for various psychiatric and neurological disorders.
We are proud to have been recognized as an employer of choice by many national organizations. In 2024 and 2025, we were certified as a Great Place to Work in the U.S. and named one of Massachusetts' Top Places to Work by the Boston Globe, a Best Place to Work in Greater Cincinnati by the Cincinnati Business Courier and recognized as a Best Place to Work in BioPharma by Fortune Magazine.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
Job Tags
Full time, Work at office, Local area, Flexible hours, 3 days per week